IA #86-07, REVISION 11/18/99 - IMPORT ALERT #86-07, "DETENTION WITHOUT
PHYSICAL EXAMINATION AND GUIDANCE OF NON-PRESCRIPTION SUNGLASSES"
NOTE: This revision changes the name of the alert and updates the alert to the
current format and terminology. In addition, this revision creates an
attachment which lists firms whose sunglasses are subject to detention
without physical examination.
TYPE OF ALERT: Detention without Physical Examination and Guidance
Note: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s)and/or product(s) at
issue. It does not create or confer any rights for or on any
person, and does not operate to bind FDA or the public.
PRODUCTS: Sunglasses, Non-prescription (Including photosensitive)
PRODUCT CODE: 86HQY
PROBLEM: Failure to have impact resistant lenses
(OASIS charge code = NOT IMPACT)
Failure to provide impact resistant certification
(OASIS charge code = LENS CERT)
PAF: PER (Performance)
LBL (Labeling)
PAC: 82008
COUNTRY: Guidance - All (999)
Detention without Physical Examination - see Attachment
MANUFACTURER/
SHIPPER: Guidance - All
Detention without Physical Examination - see Attachment
CHARGE: For Detention without Physical Examination and for products for
which testing has confirmed the certification is invalid:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to fail to comply with
21CFR801.410 [Adulteration, Section 501]"
For products that lack certification: "The article is subject to
refusal of admission pursuant to Section 801(a)(3) in that it
appears to not have been tested for impact resistance as required
by 21CFR801.410 [Misbranding, Section 502]"
RECOMMENDING
OFFICE: SAN-DO (HFR-PA152) and CDRH (HFZ-330)
REASON FOR
ALERT: Sunglasses imported into the United States must comply with the
Impact Resistant Lens Regulation, 21CFR801.410. A certificate to
comply with 21CFR801.410(g) must accompany each entry of
sunglasses showing that they have been sampled and tested using a
method which employs a statistically significant number of units
such as ANSI/ASQC ZI.4, which has replaced MIL-STD 105E, and that
they meet an AQL of 6.5 when when tested by the drop ball test or
an equal or superior test.
It has been reported that certificates from foreign manufacturers
may not be valid. Tests by one U.S. distributor revealed 40-70%
breakage which differed significantly from the manufacturer's
certificate.
Because of apparent certificate irregularities SAN-DO recently
collected a sample of childrens sunglasses. The manufacturer's
certificate indicated that no lenses broke during testing. WEAC
testing of the sample found that nearly every lens broke
completely.
GUIDANCE: Districts may detain without physical examination all non-
prescription sunglasses from the manufacturer's listed in the
attachment to this alert.
Districts may detain all shipments of non-prescription sunglasses
not accompanied by a certificate showing the lenses meet an AQL of
6.5 when tested by the drop ball test or an equal or superior
test.
If certificate irregularities are noted sample collection may be
warranted. Prior to collecting samples, districts should contact
WEAC to determine they can handle the samples on a timely basis.
Products that fail FDA testing should be referred to DIOP for DWPE
consideration.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301)443-3320 or 3007.
FOI: No purging is required.
KEYWORDS: Sunglasses, Impact Resistant
PREPARED BY: Doug Randes, DIOP, 301-443-6553.
Attachment to Import Alert #86-07 Firms subject to detention without
physical examination - 4/21/05
FIRM NAME AND ADDRESS PRODUCT
Hang Chow Industrial Co., LTD. Non-prescription Sunglasses
aka
Shye I Glasses Enterprises Co., Ltd.
9f, 253 Chungsiao E. Rd. Sec. 3
Taipei, Taiwan
FEI# 3002427048
|
