Innotech USA, Inc 11/16/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire AvenueSilver Spring, MD 20993
NOV 16, 2011
via UNITED PARCEL SERVICE
NOTIFICATION OF NONCOMPLIANCE
Dr. Pavel Efremkin
Innotech USA, Inc.
777 Old Saw Mill River Rd Ste 205
Tarrytown, New York 10591-6703
Ref: Establishment Inspection Report
Dear Dr. Efremkin:
This letter is written to advise you of items of noncompliance with the Federal Food, Drug, and Cosmetic Act (Act), Subchapter C, Electronic Product Radiation Control, Section 538(a) [U.S.C. § 360oo(a)]encountered during an inspection of Innotech USA, Inc. between June 7, 2011 and July 15, 2011.
1. 21 CFR 1040.11(a)(2). Your firm’s laser product user manuals lack the required calibration procedures and a schedule for performing such procedures. We would not object to a disclaimer to the effect that any unauthorized person performing the calibration will void the warranty, but the requirement is clear that such procedures and schedule must be provided to the purchaser.
Section 538(a) of the Act, 21 U.S.C. § 360oo(a), prohibits any manufacturer from certifying or introducing into commerce electronic products which do not comply with an applicable standard. This section also prohibits any manufacturer from failing or refusing to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered a violation of section 538(a)(4) of the Act, 21 U.S.C. 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
You are required, under 21 C.F.R. 1003.11(b), to immediately provide a written response to FDA with the number of referenced products which have been produced and the number of such products that have left the place of manufacture, and where they have been sent. Provide this information no later than 15 days after receipt of this letter and indicate one of the options listed below:
1. Refutation ‑ Under 21 C.F.R. 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failure to comply does not exist.
2. Exemption Request ‑ Under 21 C.F.R. 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in Under 21 C.F.R. 1003.10(b). You must respond within 15 days from receipt of this letter to apply for such an exemption. If exempted from such notification, you are not required to correct the violative products (under 21 C.F.R. 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 C.F.R. 1003.30 and 1003.31) and the information required under 21 C.F.R. 1003.20.
3. Purchaser Notification and Corrective Action ‑ If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 C.F.R. 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 C.F.R. 1004.1 to repair, replace, or refund the cost of the violative products.
a. Notification Letter ‑ Requirements for preparation of notification letters are prescribed in 21 C.F.R. 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
b. Corrective Action Plan ‑ Instructions for preparation of a CAP may be found in 21 C.F.R. 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the noncompliance and must be approved as set out in 21 C.F.R. 1004.6.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11(c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
In addition to the noncompliance item found during the June – July, 2011 inspection, the following failures to comply with the regulations regarding reports and record keeping were observed:
1. 21 CFR 1002.10 or 1002.11. Your firm failed to submit a product report or supplemental report on the LightPod NEO laser product.
2. 21 CFR 1002.11. Your firm failed to submit a supplemental report on the LightPod ERA laser product.
3. 21 CFR 1002.10. Your firm failed to submit a product report on the Light Lance Laser Skin Perforator.
4. 21 CFR 1002.13. Your firm failed to submit any Annual reports since 2005.
When you have completed any production changes necessary to assure compliance of future units and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce.
Your response should be sent to:
Chief, Electronic Products Branch
Division of Mammography Quality and Radiation Programs
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
10903 New Hampshire Ave., WO66-4621
Silver Spring, Maryland 20993-0002
You are also requested to send a copy of your response to:
Director, Compliance Branch
Buffalo District Office
Food and Drug Administration
300 Pearl Street Suite 100
Buffalo, NY 14202
If you have further questions on these requirements, please contact Cory Tylka of the Electronic Products Branch at Corinne.firstname.lastname@example.org
or (301) 796-5710.
Lynne L. Rice
Office of Communication, Education,
and Radiation Programs
Center for Devices and