Inspections, Compliance, Enforcement, and Criminal Investigations

Visionary Contact Lens dba Visionary 4/3/15

  

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
 
 
VIA UNITED PARCEL SERVICE                                                         
SIGNATURE REQUIRED
 
 
April 3, 2015
WL# 14-15
Mr. Richard J. Belliveau, President
Visionary Contact Lens dba Visionary
2940 E. Miraloma Ave.
Anaheim, CA 92806
 
Dear Mr. Belliveau:
 
During an inspection of your firm located in Anaheim, California on January 27, 2015 to February 26, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures rigid gas permeable contact lenses.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 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.
 
This inspection 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 
 
We did not receive a response from your firm to our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm on February 26, 2015. The violations include, but are not limited to, the following:  
 
1.    Failure to adequately validate software used as part of production and quality systems for its intended use according to an established protocol as required by 21 CFR 820.70(i). Specifically, you did not validate your CNC Lathe and MAS 90 software used in manufacturing and labeling, respectively.
 
2.    Failure to ensure that all equipment used in the manufacturing process meets specified   requirements and is appropriately placed and installed to facilitate use, as required by 21 CFR 820.70(g). Specifically, you did not document the performance of installation qualification for your DAC Lathe #1 and DAC Lathe #2.                  
 
3.    Failure to establish procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). Specifically, your Corrective and Preventative Action (CAPA) procedure does not include verification or validation activities.  
 
4.    Failure to establish and maintain procedures for implementing corrective and preventive action, including investigating the cause of nonconformities relating to product, processes, and quality system, as required by 21 CFR 820.100(a)(2) and identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3). Specifically, your Visionary Final Inspection/Fine Tune Reports (non-conformance reports) dated 12/3/14, 12/29/14, and 1/21/15 do not contain evidence of an investigation or corrective and preventative action.
 

5.    Failure to establish procedures for quality audits as required by 21 CFR 820.22. Specifically, you did not conduct quality audits in years 2011, 2012, 2013, and 2014.

 

6.    Failure to adequately establish procedures for training as required by 820.25(b). Specifically, several training records reviewed disclosed that employees were not trained in Good Manufacturing Practice, Quality, CAPA and manufacturing equipment procedures.

 

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.

Please notify this office in writing within fifteen (15) working days of receipt of 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 actions cannot be completed within 15 working days, state the reason for the delay and the time within the corrections will be completed.
 
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.  
 
Your response should be sent to:
 
CAPT Daniel Cline, Acting Director
Compliance Branch
Attn: Dr. Raymond W. Brullo
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
 
Sincerely yours,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
Cc:
 
David M. Mazzera, Branch Chief 
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Ave, MS-7602
Sacramento, CA 95899-7413
Attn: FDA correspondence

 

Page Last Updated: 06/27/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English