Inspections, Compliance, Enforcement, and Criminal Investigations
AES Optics 11/18/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
November 18, 2010
WARNING LETTER NO. 2011-NOL-03
UNITED PARCEL SERVICE
Delivery Signature Requested
Wade H. Whitley, President
201 Corporate Court
Senatobia, Mississippi 38668
Dear Mr. Whitley:
During an inspection of your firm, located in Senatobia, Mississippi, on May 13, 18, and 20, 2010, an investigator from the United States Food and Drug Administration (FDA) determined your firm to be the specifications developer, thus manufacturer, of UVA and UVB protection sunglasses. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 351(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.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because 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 requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820).
The investigator's observations were noted on a Form FDA 483, Inspectional Observations, issued to you on May 20, 2010. These violations include, but are not limited to, the following:
1. Failure to establish a quality plan [21 CFR 820.20(d)]. There is no agreement with the contract manufacturer to follow specifications or to interact with the owner of the device. There is no procedure or evidence the contract manufacturer contacts AES Optical when non-conformances occur.
2. Failure to establish written procedures for a third party to conduct quality audits (21 CFR 820.22). A third party is performing quality testing on the protective lens, but no procedures have been established for the third party firm.
3. Failure to establish written procedures to cover Corrective and Preventive Action (CAPA) [21 CFR 820.100(b)]. There is no CAPA in place to cover product failure.
4. Failure to establish and identify valid statistical techniques needed for UV testing of UV protective sunglasses [21 CFR 820.250(a)]. There is no agreement with the contract manufacturer or written procedures for testing finished devices.
5. Failure to establish and implement Medical Device Reporting procedures (21 CFR 803.17).
6. Failure to establish written criteria for workmanship expressed in documented standards or by means of identified and approved representative samples [21 CFR 820.70(a)(5)]. There are no specifications or directions to test the UV protective sunglasses for effectiveness.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all warning letters regarding devices so they may take this information into account when considering the award of contracts. Premarket approval applications for Class III devices to which the QS 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 fifteen (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 violation, from occurring again. Include documentation of the corrective action you have taken. 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.
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 Form 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.
Your response should be addressed to Karl L. Batey, Compliance Officer, US Food and Drug Administration, at the above address. If you have any questions about the content of this letter please contact Ms. Batey at (615) 366-7808.
Patricia K. Schafer
Acting District Director
New Orleans District