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
60 Eighth Street, N.E.
Atlanta, GA 30309 |
DATE(S) OF INSPECTION
2-3-14/03 |
FEI NUMBER
(blank) |
NAME
AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED (Hand
written)
TO: Connie J. Jones, Senior Director RA/QA |
FIRM
NAME
Cryolife |
STREET
ADDRESS
1655 Roberts Blvd., NW |
CITY,
STATE AND ZIP CODE
Kennesaw, GA 30144 |
TYPE OF
ESTABLISHMENT INSPECTED (Hand written)
Human Tissue Processor/Medical Device Manu |
DURING
AN INSPECTION OF YOUR FIRM I OBSERVED: 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.
-
- The firm did not retrieve allografts that are known to be
associated with infections (processed prior to the FDA Recall Order 8/12/02) from
the market. At least twelve distributed allografts are associated with reported
Clostridium, Candida, or E.Coli infections. No actions had been taken by the firm at the
initiation of the current inspection (2/5/03). [Handwritten: corrected not verified
2/14/03 cdb]
- The firm reportedly conducted a review (look back) of all
allografts processed between 1998-2002. There was no established plan, procedures or
corrective action request (CAR) detailing this review. [Handwritten: Corrected:
verified 2/14/03 cdb]
- The complaint handling system is deficient in that:
- The firm did not document and/or follow-up on a complaint
received on 1/2/03 from the agency through Medwatch [ Redacted ] for allograft [ Redacted
] . The heart valve is reported to have been infected with Aspergillus 2 years ago and
most recently with Staphylococcus. [Handwritten: (9-5-02)] The complaint was not
investigated and, the firm did not file an MDR upon notification of the incident. [Handwritten:
corrected not verified 2/14/03 cdb]
- Many complaints are incomplete and/or the files are
disorganized. For example,
- The firm did not have complete follow-up for complaint
(#02-5210367). The complaint (reported to Cryolife on 9/10/02) indicated that a femoral
vein was implanted 5/24/02 and the patient developed an infection not normally acquired
through other exposures. The complaint report heavy growth of Corynebacterium. Heavy
growth mixed anerobes including prevotella species. No complaint summary and limited
follow-up reports were available in the complaint file when requested on 2/5/03. The
complaint was still outstanding. [Handwritten:Corrected : verified 2/14/03 cdb]
- As of 2/10/03 the firm has at least 20 incomplete complaint
investigations as that have been outstanding for 174- 255 days. [Handwritten:
Under consideration 2/14/02]
- Complaints #02-5210373, #02-5210372, #02-5210326 have been
assigned however, specifics about these complaints have not been documented. [Handwritten:Corrections
promised 2/21/02]
- As of 1/31/03, the firms complaint files contained 72
open complaints. The complaints have been in open status 144 days (4.5 months)
or longer. The complaint investigations have not been reviewed and final dispositions have
not been determined. [Handwritten: Under consideration 2/14/03]
- The firms QA unit does not have oversight for
complaint handling and does not review the complaints, complaint investigations or
complaint corrective actions/follow-up. [Handwritten: Corrected not verified]
- The firms bacteriostasis/fungistasis testing on the
anti-microbial cocktail for [ Redacted ] failed to establish consistent hold times across
all challenge organisms and anti-microbial solutions. [Handwritten: under
consideration]
- The firms bioburden program is deficient in that:
- The firm has not completed the validation protocol
and
methods development [Handwritten correction, strikethrough:Design cdb
2/14/03] to address incoming bioburden as outlined in the corrective action plan.
- As of 2/11/03 the firm has not
analyzed [Handwritten
correction, strikethrough: trended cdb 2/14/03] the cumulated bioburden data from [
Redacted ] which began in June 2002.
- The firm does not perform an assessment into the root cause
when donor [Redacted] showing different organisms.
For example:
Donor ID |
Pre-culture
Results |
Post-Culture
Results |
[Redacted] |
Streptococcus pyogenes |
Propionbactrium acnes |
[Redacted] |
Enterobacter aerogenes |
Propionbactrium acnes |
[Redacted] |
Negative Staphpylococcus |
epidermidis |
[Redacted] |
Pseudomonas fluorscens |
Pseudomonas aeruginosa |
[Handwritten: Item under consideration 2/14/03 cdb]
- The firm has not performed the following equipment
qualification:
- The three [Redacted ] being used on human tissue (EO113F,
EO113J, EO113G) did not have complete validation; the Performance Qualifications were not
done. [Handwritten: Corrected not verified 2/14/03 cdb]
- Current Preventative Maintenance procedures for the
[Redacted ] are not in accordance with the manufacturers recommendations. [Handwritten:
corrected not verified 2/14/03 cdb]
- On 2/3/03 an area of rust/corrosion was observed along the
bottom back panel of Laminar flow hood (E00491) located in the Microbiology Lab. [Handwritten:
corrected not verified 2/14/03 cdb]
|
SEE REVERSE OF THIS PAGE |
EMPLOYEE(S) SIGNATURE
[Handwritten Signatures]
Claudette D. Brooks, CSO
Karen A. Coleman, CSO
Mary Alice Papdimitriou, CSO
Paul Bonneau, Microbiologist |
EMPLOYEE(S)
NAME AND TITLE (Print or Type)
Claudette D. Brooks, CSO
Karen A. Coleman, CSO
Mary Alice Papdimitriou, CSO
Paul Bonneau, Microbiologist |
DATE ISSUED (Hand
written)
2/14/03 |
FORM FDA 483 (8/00) 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." |
Web page created by ORA Web Team 03/07/2003
|