| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesJanuary 24, 2011
WARNING LETTER
Refer to MIN 11 – 13
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Christopher B. Gregg
Owner
Costumes For Your Eyes
6175 Cahill Avenue East, #101
Inver Grove Heights, Minnesota 55076
Dear Mr. Gregg:
During an inspection of your firm located in Inver Grove Heights, Minnesota, on October 4-15, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures decorative, corrective and non-corrective rigid and soft contact lenses. As you were advised at that time, contact lenses are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h). These products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that the decorative, corrective and non-corrective rigid and soft contact lenses are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You are also required to submit annual registration information for each establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a device under section 510(b)(2) of the Act, 21 U.S.C. § 360(b)(2). In addition, under section 510(j)(2) of the Act, 21 U.S.C. § 360(j)(2), you are required to annually report a list of each device you introduced for commercial distribution which has not been included in any list you previously filed with FDA, in addition to other information. You are required to submit annual registration and listing information during the period beginning on October 1 and ending on December 31 [sections 510(b)(2) and (j)(2) of the Act]. Annual registration and listing information for fiscal year 2010 were required to be completed by December 31, 2009. Our records indicate that you have not yet fulfilled your annual registration and listing requirements for fiscal year 2010.
Our inspection also revealed that your devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (21 CFR), Part 820. The violation includes, but is not limited to, the following:
Failure to establish and maintain a quality system that is appropriate for the specific medical device designed or manufactured, as required by 21 CFR 820.5.
For example, your firm did not establish a quality system. Procedures regarding management controls, design controls, corrective and preventive actions, or production and process controls have not been defined, documented, or implemented. In addition, your firm does not have procedures for documenting complaint handling activities, supplier controls, or control of non-conforming products.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Demetria Lueneburg, Compliance Officer. If you have questions about the content of this letter please contact Ms. Lueneburg at (612) 758-7210.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
DLL/ccl
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