IA #95-02, 8/13/01, "DWPE OF INFRARED VISION LASER ILLUMINATORS AND SCOPES
FROM RUSSIA THAT INCORPORATE A LASER ILLUMINATOR"
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE)
NOTE: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or products(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. ***
PRODUCT: Infrared Laser Illuminators (a.k.a. night vision illuminators and
scopes which incorporate a laser illuminator). Scopes without the
laser illuminator are not subject to DWPE.
PRODUCT
CODE: 95L[][]22
PROBLEM: Fails to Meet Performance Standard
PAF: PER (Performance)
PAC: *** 86007 ***
COUNTRY: *** Russia (RU) ***
MANUFACTURER
ID: *** All manufacturers from Russia
See attachment for firms known to manufacture and ship infrared
night vision laser illuminators and scopes.***
IMPORTER'S
ID: N/A
CHARGE: If device is noncompliant with applicable standard and/or lacks
certification, charge:
"The article is subject to refusal of admission pursuant to
Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
in that it appears to be an electronic product which fails to
comply with an applicable standard as prescribed under this
subchapter or to which is not affixed a certification in the form
of a label or tag in conformity with Section 534(h)."
If no reporting is done, charge:
"The article is subject to refusal of admission pursuant to
Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
in that it appears to be an electronic product that does not
comply with an applicable standard as prescribed by Section 534
because no reporting has been provided as required by Section
537(b)."
OASIS CHARGE
CODE: No Tag
RECOMMENDING
OFFICE: CDRH, OC, Division of Compliance Operations (HFZ-323)
REASON FOR
ALERT: CDRH/Division of Compliance Operations has identified infrared
night vision laser illuminators and scopes from Russian
manufacturers as violating Sections 536, 537 and 538 of the FFDCA
and 21 CFR 1002.10 and as being potentially hazardous laser
products. The products have no certification that complies with
the appropriate performance standard for laser products and no
initial report from Russian manufacturers have been received by
CDRH.
GUIDANCE: *** Districts may detain without physical examination infrared
night vision laser illuminators and scopes from Russia lacking
certificates, initial reports, or user instructions. Products
should be refused entry unless the importer corrects the product
deficiencies or is able to show that the product is properly
certified and meets the performance Standards (21 CFR 1010.2 and
1010.3). It may be necessary to field test some products to
ensure the importer has effected the correction of the detained
product. Contact CDRH at (301) 427-1172 for additional guidance.
Also contact CDRH for information regarding submission of required
reports and guidelines for detention.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605. ***
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required
KEYWORDS: Infrared Night Vision, Infrared Laser Illuminators, Night Vision
Scopes, Night Vision Laser Illuminators, Scopes
PREPARED
BY: Linda A. Wisniowski, DIOP, (301) 443-6553.
DATE LOADED
INTO FIARS:
IMPORT ALERT #95-02 ATTACHMENT 8/30/01
FIRMS RECOMMENDED FOR DWPE KNOWN RUSSIAN MANUFACTURERS/SHIPPERS OF INFRARED
NIGHT VISION LASER ILLUMINATORS AND SCOPES
NIMP
Novosibrisk, Siberia
Russia
FEI #1000134061
Ratio
Ul. Tvardovskogo, 5-3-426
Moscow, 123, Russia
FEI #1000141916
Rostov Optical-Mechanical Plant
(or Rostovskiy Optico-Mechanicheskiy Plant)
Savinskoye, Schosse
Rostov, Yaroslavl Region 152100
Russia
FEI #1000134060
Rotan
78 Jurinsky Street
Novo Sibrisk
Russia
FEI #1000141780
Talus Corporation
Malyi Momsomolskyi Per, 6
Moscow, 101863
Russia
FEI #1000141781
VIZIR
5-2 Autonova-Voseenko St.
Moscow,Russia
FEI #1000141779
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