Inspections, Compliance, Enforcement, and Criminal Investigations

Advanced Vision Science Inc 4/6/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
April 6, 2016
WL# 26-16
Cynthia A. Bentley, President/CEO                                                                                                                                                      
Advanced Vision Science Inc.
5743 Thornwood Dr.                                                                                                                         
Goleta, CA 93117-3801
 
Dear Ms. Bentley:
 
During an inspection of your firm located in Goleta, California, conducted from July 27, 2015 through August 3, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm operates as a manufacturer and distributor of intraocular lenses (IOL) devices including, but not limited to, 3-piece and single piece lenses. Under 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 to affect the structure or any function of the body.
 
This inspection revealed that these 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 
 
A response from your firm concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, was sent by email to the investigator on August 24, 2015. The response is addressed with each violation below. Noted violations include, but are not limited to, the following:  
 
1.    Failure to establish procedures for receiving, reviewing, and evaluating complaints for Medical Device Reporting as required by 21 CFR 820.198(a)(3). For example, your Complaint Handling Procedure lacks detail as to how complaints are evaluated for Medical Device Reporting. Your response is inadequate in that it states that you will be reviewing your Quality and Complaint Handling systems. The results of that review have not been provided.
 
2.    Failure to establish procedures for finished device acceptance as required by 21 CFR 820.80(d). For example, you do not maintain procedures that address acceptance criteria at your customers or your own acceptance criteria [e.g. tooling marks]. Your response is inadequate in that it states that you have stopped shipment of IOLs in the United States and are considering a Humanitarian Device Exemption [HDE]. The results of your consideration of an HDE have not been provided.
 
3.    Failure of the design history file to demonstrate that the design was developed following the approved design plan and does not demonstrate that the design was developed following the requirements of 21 CFR 820 as required by 21 CFR 820.30(j). For example, your design history file does not have the location of design documents or changes you made to the (b)(4) lens.   Your response is inadequate as you state that you no longer maintain design records after your transfer of a PMA to Bausch & Lomb.   Your response also states that you have stopped shipment of IOLs in the United States and are considering a Humanitarian Device Exemption. The results of your consideration of an HDE have not been provided.
 
Our inspection also revealed that the (b)(4) IOLs are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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) for the device as described and marketed.
 
Specifically, the Establishment Inspection Report (EIR) revealed that in March 2009, your firm transferred (sold) the PMA and licensed all development, manufacturing, and marketing to another firm for all regions except Japan. However, the inspection found that although your firm claimed that it was only distributing the IOLs in Japan, evidence shows that you distributed the (b)(4) and (b)(4) IOLs into the U.S. since 2008 and 2012 respectively. That is, lenses for the Japanese market that may be refused based on acceptance criteria are returned to Advanced Vision Science (AVS) and donated/distributed into intrastate commerce for further distribution.
 
A review of the FDA Premarket Approval (PMA) database revealed that AVS does not have any approved PMA to market a device in the United States after your firm transferred (sold) PMA P830033 in March 2009. 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 C.F.R. 807.81(b). The kind of information your firm needs to submit in order to obtain approval for your device is described on the Internet at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm#step2. The FDA will evaluate the information your firm submits and decide whether your product may be legally marketed.
 
Your firm stated in your written response dated February 16, 2016 that effective August 3, 2015, you suspended the distribution of all intraocular lenses within the United States. Our Office requests that AVS continues to cease activities that result in the misbranding or adulteration of the intraocular lenses, such as the commercial distribution of the device for the uses discussed above.
 
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. 
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your response should be sent to:
 
CAPT Daniel Cline, Acting Director
Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or raymond.brullo@fda.hhs.gov .
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by the FDA.
 
 
Sincerely,
/S/ 
LCDR Steven Porter
Acting Director
Los Angeles District
 
 
cc:
 
David M. Mazzera, Ph.D., Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence

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