Note: Although this FDA-483 is an
accurate representation of the original FDA-483 issued to the firm, it is not an exact
copy. Slight modifications to the original FDA-483 have been made to accommodate its
conversion to the HTML format. A scanned copy of the original FDA-483 is available in PDF format on this website. |
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
DISTRICT
OFFICE ADDRESS AND PHONE NUMBER One
Montvale Avenue
Stoneham, MA 02180
(781) 596-7700 Fax:(781) 596-7896
|
DATE(S)
OF INSPECTION 03/09/2005 - 04/07/2005* |
FEI
NUMBER 1219544 |
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Mark S. Adams, Quality Manager |
FIRM
NAME
Boston Scientific Corporation |
STREET
ADDRESS
480 Pleasant Street |
CITY,
STATE AND ZIP CODE
Watertown, MA 02472 |
TYPE
OF ESTABLISHMENT INSPECTED
Manufacturer |
This document lists
observations made by the FDA representative(s) during the inspection
of your facility. They are inspectional observations, and do not
represent a final Agency determination regarding your compliance.
If you have an objection regarding an observation, or have implemented,
or plan to implement, corrective action in response to an observation,
you may discuss the objection or action with the FDA representative(s)
during the inspection or submit this information to FDA at the address
above. If you have any questions, please contact FDA at the phone
number and address above. |
The observations
noted in this Form FDA-483 are not an exhaustive listing of objectionable
conditions. Under the law, your firm is responsible for conducting
internal self-audits to identify and correct any and all violations
of the quality system requirements. |
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Not all of the actions needed to correct and prevent the recurrence
of nonconforming product and other quality problems have been identified.
Specifically, the three non-valved Vaxcel Low Profile Plastic
Ports were not included in the recall of the Vaxcel with PASV Valve
Low Profile Port affected by the port separation issue, although
a similar ultrasonic welding process is used for the non-valved
ports. The Recall Letter states that the firm has received
reports that the port housing has separated after implantation,
and that this, "can result in leakage of infusates and have
potentially significant adverse health consequences."
- Both the valved and non-valved
port subassemblies consist of a cover, a base and a septum. With
the septum installed, the cover and base are ultrasonically welded
together. The ultrasonic welding process for the non-valved
ports was not validated. The justification was that the
process is identical to that used for the valved ports.
- The valved ports have a
history of port separation - the cover and base have separated
while implanted. Boston Scientific Corporation (BSC) received
[REDACTED] complaints of port separation between August 2004
and February 2005.
- BSC conducted a field
action by recalling the valved ports, both hospital inventory
as well as implanted units, in March 2005.
- No field actions have
been taken on the non-valved ports.
|
OBSERVATION 2
The acceptance status of product was not clearly identified throughout
installation and servicing of the product.
Specifically, although product was placed on Precautionary Shipping
Hold on August 25, 2004, customers were not notified of the problem
of port separation on the Vaxcel Low Profile Ports with PASV technology,
until the recall letters were actually sent out to customers on
March 11, 2005. The firm’s decision to recall was not
recommended to the field action committee until 3/3/05. The
recall affects both hospital inventory, as well as implanted ports. Customers
were not notified separately not to use product in inventory. |
OBSERVATION 3
A process whose results cannot be fully verified by subsequent
inspection and test has not been adequately validated and approved
according to established procedures.
Specifically, validation of the ultrasonic weld on the Vaxcel
Low Profile Ports, both with and without Pressure Activated Safety
Valves (PASV), was inadequate. The ports are subassemblies
used in the Vaxcel Implantable Vascular Access System.
For valved ports (those with PASV): Document #90052957 ver.
AB, Plastic PASV Single Lumen Port Ultrasonic Welding Operational
and Process Qualification Test Report, release date 2/19/03,
included [REDACTED] which was conducted at [REDACTED]. This
did not take into account a safety factor for degradation of the
product in the body. There was no tensile test included
in the validation. There was no actual or simulated clinical
use testing performed. The validation was conducted on units
manufactured by R&D personnel rather than production personnel. The
validation was conducted on units manufactured prior to incorporating [REDACTED] during
the welding process. Production units were all manufactured
subsequent to incorporating [REDACTED]. The
post-welding inspection procedure, Document 90038661 ver. AC In-Process
Inspection of the Port Welded Assembly, includes only visual
and cosmetic inspections.
The non-valved ports (those without PASV) did not receive an Operational
Qualification/Process Qualification (OQ/PQ) test. Change
Manager #546297 dated 4/23/03, Described as "OQ/PQ Test Report
NV Port Base & Cover" states on page 3 regarding welding
of the non-valved ports: "Process is identical to the
Std Plastic Port. No further testing required." There
is a difference in the valved and non-valved welding process parameters: the
port welding procedure for the valved ports (Document #90033786
ver. AE SL Port Welding Procedure) includes a [REDACTED];
the port welding procedure for the non-valved ports (Document #90052347
ver. AB Mini Port Welding Procedure) includes a [REDACTED].
——
Annotation: Promised to correct by 6/7/2005 for valved, and
9/30/2005 for non-valved. |
OBSERVATION 4
A validated process was not revalidated when changes or process
deviations occurred.
Specifically, the ultrasonic weld OQ/PQ test was not done for
the valved Vaxcel with PASV Low Profile Ports following the change
on 7/10/2003 to sand the port bases. The validation of the
change consisted only of verifying that the height of the base
was still within specifications, prior to welding.
——
Annotation: Promised to correct by 6/7/2005.
|
OBSERVATION 5
Procedures were not defined for the control of products that do not
conform to specifications.
Specifically,
Procedures are lacking to assure consistency in handling and timing
activities from complaint receipt, complaint trending, ship hold, PIR
initiation, and field action determination, to actual recall. There
were inconsistencies for the 3 recalls on Vaxcel products with subassemblies
manufactured at this site:
- For Product Inquiry Report (PIR), #WAT-2004-01-02,
for the recall of the Vaxcel with PASV Titanium 8 Fr Mini Port
involving catheter separation and catheter migration:
- Although the preset complaint
alert limit [REDACTED] was exceeded for November
2003, December 2003, and January 2004, as stated on the PIR, the
product ship holds were not initiated until 1/30/04 and 2/4/04.
- The Clinical Assessment for Detection
(PIR section IIIA) is listed as "High" with a rationale for choice
of "The leakage is likely to get noticed during infusion
of the fluids."
- The Clinical Assessment for Severity
is listed as 4-Critical, and the separate box is checked under
total score for "Any Severity Factor (Severity 4 or above
= Unacceptable Risk)"
- The Recommendation for
Field Action for recall was signed as approved by the Business
Group VP of Quality on 2/13/04, and by the Field Action Committee
(FAC) Chairperson on 2/13/04 (3 months after identifying the
trend, and 1-2 weeks after the ship holds).
- For PIR #WAT-2004-09-01, for the recall of
the Vaxcel with PASV PICC - Single Lumen 4-3 involving catheter
fractures and catheter migration:
- Although the complaint rates
listed on the PIR for July, August and September 2004, each
exceeded the [REDACTED] preset upper control limit (UCL),
the product ship hold was not initiated until 10/1/04.
- The complaint rate for
August 2004 is shown as [REDACTED] based on [REDACTED] complaints [REDACTED],
with a note that although [REDACTED] additional complaints
were phoned in for that month, the events happened in January 2004-July
2004.
- The Clinical Assessment for Detection
(PIR section IIIA) is listed as "Low" with a rationale for choice
of "Separation of the catheter distal to the suture wing
may not be easily detectable and therefore may not prevent
the leakage of infusion fluids or catheter migration."
- The Clinical Assessment for Severity
is listed as 4-Critical, and the separate box is checked under
total score for "Any Severity Factor (Severity 4 or above
= Unacceptable Risk)"
- The Recommendation for
Field Action for recall was signed as approved by the Business
Group VP of Quality on 10/28/04, and by the FAC Chairperson
on 12/1/04 (5 months after identifying the trend, and 2 months
after the ship hold).
- For PIR #WAT-2004-08-01, for the recall of the
Vaxcel Low Profile w/ PASV Ports involving port separation, there are
two revisions of the PIR. Revision AA is dated 9/17/04. Revision
AB is dated 2/23/04, however should have been dated 2/23/05:
- The complaint rate for
August 2004 listed on the local trend report is [REDACTED],
and a product ship hold was initiated on 8/25/04.
- The complaint rate for
August 2004 shown on the PIR rev. AA, section [REDACTED].
- The complaint rate for
February shown on the PIR rev. AB, section IIA, is [REDACTED] based
on [REDACTED] complaints. BSC
actually received [REDACTED] complaints of
port separation between August 2004 and February 2005: 8/19/04, 9/2/04, 10/19/04, 11/16/04,
and 2/9/05. The Quality Manager said that only [REDACTED]of
these complaints were confirmed.
- The local trend report
shows complaint rates of:
[REDACTED] for
September 2004 based on [REDACTED] complaint and [REDACTED] shipments;
[REDACTED] for
October 2004 based on [REDACTED] complaints and [REDACTED] shipments;
[REDACTED] for
November 2004 based on [REDACTED] complaint and [REDACTED] shipments;
[REDACTED] for
December 2004 based on [REDACTED] complaints and [REDACTED] shipment;
[REDACTED] for
January 2005 based on [REDACTED] complaints and [REDACTED] shipments;
and
[REDACTED] for
February 2005 based on [REDACTED] complaint and [REDACTED] shipment.
- On Rev. AA, the Clinical
Assessment for Severity is listed as 4-Critical, however the
separate box is not checked
under total score for "Any Severity Factor (Severity 4
or above = Unacceptable Risk)"
- On Rev. AB, the Clinical
Assessment for Severity is listed as 4-Critical, however the
separate box is not checked
under total score for "Any Severity Factor (Severity 4
or above = Unacceptable Risk)"
- On Rev. AA, the Recommendation
for NO Field Action (PIR section V) is approved by the Business
Group VP of Quality on 9/27/04, and by the FAC Chairperson
on 9/29/04.
- On Rev. AB, the Recommendation for Field
Action for recall is approved by the Business Group VP for
Quality on 3/4/05, and by the FAC Chairperson on 3/3/05 (5 ½ months
after the ship hold).
The PIR procedure (90030420 Corporate SOP Product Inquiry Procedure)
says to include the rate of complaints per month, but does not explain
how to determine the rate of complaints (i.e. the number of complaints
received that months vs. the number of events that occurred that month).
The complaint trending procedure (S808543-00 rev. AC Complaint
Trending) identifies a complaint rate pre-set upper control limit
(UCL) of [REDACTED], as well as a statistical UCL. The
procedure states that a Complaint Trending Report will be generated
each month for specific products including, but not limited to, the
products for which Complaint Evaluation is conducted at the facility. Although
the port separation issue is being investigated at the Watertown,
MA facility, the Quality Manager stated that this procedure is local
to the Watertown, MA facility, and does not apply to the Vaxcel ports
since the official complaint trending site for the ports is the Glens
Falls, NY facility. He said he chooses to track this data for
the Vaxcel ports for his own information.
The Glens Falls procedures (QA-004.EE Product Complaint and MDR
Processing; and QA-094.C Determination of Control/Action
Limits) describe statistical UCLs, but not the [REDACTED] preset
UCL.
Neither the PIR procedure nor the complaint trending procedure states
whether to include all complaints received in a particular month, or
only those that have been "confirmed". The trend report
for Watertown appears to include all complaints received in a particular
month. The complaint rate for August 2004 listed on PIR #WAT-2004-09-01
appears to include only the complaints where the event happened in the
month of August 2004. The complaint rate listed on PIR #WAT-2004-08-01
rev. AB appears to include only the "confirmed" complaints
for the trend reported.
——
Annotation: Under consideration.
|
OBSERVATION 6
The organization structure is not adequate to assure that quality system
requirements are fully met.
Specifically, the responsibilities for a particular product family
are shared among various facilities. Process requirements are
not necessarily the same from one facility to another, or from local
procedures to the corporate procedures.
——
Annotation: Under consideration.
|
OBSERVATION 7
Procedures that describe the review and disposition process for nonconforming
product were not implemented.
Specifically, Shipping Holds for 2 instances were incorrectly classified
as Business Holds rather than Precautionary Holds. Both involved
products with subassemblies manufactured at this facility, which ultimately
resulted in product recalls. The Product Shipping Hold and Release
procedures #S842160-00, (both revs AF & AG), state that "Business
Holds" may not be "as a result of performance related issues."
-
The shipping hold for the Vaxcel with PASV 4-3
Fr Single Lumen Peripherally Inserted Central Catheter (PICC)
was initiated on 10/1/04 as a "Business Hold" for all lots of
the following 4 Material Numbers: M001454500, M001454510, M001454520,
and M001454540. The
reason for the hold is not filled out on the Notification of Shipping
Hold form. The firm's 3/10/05 memo states that the firm became
aware of a number of complaints of catheter fractures at the suture
wing connection, some of which resulted in catheter migration. A
recall was initiated on 12/3/04, as stated in the same memo.
-
The shipping hold for the Vaxcel with PASV 8Fr
Mini Titanium Port was initiated on 2/4/04 as a "Business Hold" for
9 lots of Material Number M001453620, and 2 lots of Material Number
M001452380. The reason for the hold is "Design-Related". This
followed the 1/30/04 Shipping Hold for Material Number M001452150 which
was classified as a "Precautionary Hold". The firm's
3/10/05 memo states that the firm became aware of a number of
complaints for catheter separation from the port connector, some
of which resulted in catheter migration.
——
Annotation: Under consideration.
|
OBSERVATION 8
The device history record does not demonstrate the device is manufactured
in accordance with the device master record.
Specifically, 43 of 55 shop floor paperwork (SFP) records reviewed
were missing elements. These SFP records included welded port
subassemblies, molded port bases and molded port covers.
- Nine (9) SFPs were missing one or more of the
following fields of data on the Injection Molding Process Log
Sheet: cushion
data, rear zone, middle zone, mold temperature, and/or back pressure. The [REDACTED] temperature
(rear and middle zone recordings) and [REDACTED] temperature
are considered "critical process parameters (Inputs)" according
to the firm's memorandum dated 3/28/03. Two (2) of these 9 SFPs
were missing critical parameters: lot 5566779 (non-valved
port base - missing Rear Zone data and Middle Zone data); and
lot 5470571 (valved port base - missing the [REDACTED] Temperature).
- Three (3) SFP records were lacking the Injection
Molding Process Log Sheet altogether.
- 38 SFPs were lacking time and/or initials on
the Injection Molding Process Log Sheet.
- Five (5) SFPs were missing the shift and/or
date of the technical set up on the Injection Molding Process Log
Sheet.
- One (1) SFP was missing the lot number.
- Three SFP records containing hand-written
corrections to the pre-printed order quantity, did not have dates next
to the initials for the corrections. SOP S800149-01, rev. AF, In-Process
Handling of Product for Inspection, requires that, "any
changes to pre-printed information are to consist of, item crossed
out, new item written in, initialed and dated by proper signatory."
——
Annotation: Promised to correct within 30 days.
|
OBSERVATION 9
Procedures for acceptance or rejection of incoming product were not
defined, documented, and implemented.
Specifically,
- Seven of nine incoming material inspection records
showed acceptance stickers with "Accept Dates" prior to
the actual accept date listed on the documents.
- Eight of nine incoming material inspection records
were missing the accept date next to the inspector's handwritten initials. SOP
9610001-01 rev AY, Incoming Material Inspection, requires
the date in addition to the inspector's initials.
——
Annotation: Reported corrected, not verified.
|
* DATES OF INSPECTION
03/09/2005(Wed), 03/10/2005(Thu), 03/11/2005(Fri), 03/15/2005(Tue),
03/18/2005(Fri), 03/22/2005(Tue), 03/29/2005(Tue), 04/05/2005(Tue),
04/07/2005(Thu) |
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
[Handwritten Signature]
Elizabeth B. Griffin, Engineer/Investigator
[Handwritten Signature]
Carla C. Cummins, Investigator
[Handwritten Signature]
Darin S. Wiegers, Investigator
|
SEE
REVERSE
OF THIS
PAGE |
|
|
DATE
ISSUED 04/07/2005 |
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE
INSPECTIONAL OBSERVATIONS
Reverse Text on Page: The observations of objectional conditions and practices listed
on the front of this form are reported:
- Pursuant to Section 704(b) of the Federal Food, Drug and
Cosmetic Act, or
- To assist firms inspected in complying with the Acts and
regulations enforced by the Food and Drug Administration.
|
Section 704(b) of the Federal Food, Drug, and Cosmetic
Act (21 USC374(b)) provides: “Upon
completion of any such inspection of a factory, warehouse, consulting laboratory, or other
establishment, and prior to leaving the premises, the officer or employee making the
inspection shall give to the owner, operator, or agent in charge a report in writing
setting forth any conditions or practices observed by him which, in his judgement,
indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole
or in part of any filthy, putrid, or decomposed substance or (2) has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy of such report
shall be sent promptly to the Secretary.” |
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