Inspections, Compliance, Enforcement, and Criminal Investigations
Visionary Contact Lens, Inc. 01-Jun-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
Richard J . Belliveau
Visionary Contact Lens, Inc .
2940 E. Miraloma Ave.
Anaheim, CA 92806
Dear Mr. Belliveau:
Your firm manufactures medical devices. During an inspection of your manufacturing facility located in Anaheim, California, conducted between November 1 and 21, 2005, our investigators found significant deviations from the Current Quality System Regulations (QSR) for finished devices (Title 21, Code of Federal Regulations, Part 820). Such deviations cause human devices manufactured at this facility to be adulterated within the meaning of Section 501(h) of the Federal Food, Drug and Cosmetic Act (henceforth the "Act").
Section 501 (h) of the Act states that a device shall be deemed adulterated if the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installation do not conform to or are not administered in conformity with current Quality System Regulations, to assure that such device will be safe and effective.
Our inspection found the following device QSR deficiencies:
1. Not all complaints you have received have been reviewed and evaluated to determine whether an investigation is necessary. Specifically, you received 34 complaints during 2005. 26 of these complaints have no documentation of investigation to determine the root cause. [21 CFR 820.198(b)]
2. You have not identified and/or analyzed all quality data to identify existing and/or potential causes of nonconforming product or other quality problems. Specifically, you have not documented the reason and/or conducted an investigation as to the cause of rejected lenses. Additionally, your complaint records do not contain sufficient information to conduct a thorough investigation. [21 CFR 820.100(a)(1) & 820.100(a)(2)]
3. You have not documented acceptance activities performed for in process product. Specifically, you have no documentation to support acceptance activities during production including the individual performing the evaluation, the equipment used, and/or the results of any such evaluation. [21 CFR 820.80(e)]
4. You have not documented justification for the use of nonconforming components such as previously rejected and/or partially processed lens buttons. [21 CFR 820.90]
5. Your device history records do not demonstrate that your finished products are manufactured in accordance with your device master records. Specifically, your device history records do not include copies of all labeling for each finished device and the rework of contact lenses is not documented. [21 CFR 820.184]
6. You have not validated software used in the production of finished medical devices. Specifically, you have not validated the software use with the lathes used in the manufacture of contact lenses nor have you validated the software use to store information that is part of the device history records. [21 CFR 820.70(i)]
7. You do not have device master records for each product you manufacture. Specifically, you lack device master records for 4 styles of contact lenses. [21 CFR 820.181(a)]
8. You have not established, defined and documented corrective and preventive action procedures. [21 CFR 820.100(b)]
9. You have not completely established procedures to ensure that equipment is routinely calibrated. Specifically, the daily check of manufacturing equipment is not described or referenced. [21 CFR 820.72(a)]
10. You have not completely established procedures to ensure that management reviews are adequate. Specifically, your procedure only identifies CAPA as the quality data source and your procedure does not require documentation of the date and results of such management review. Additionally, you have not documented any management reviews. [21 CFR 820.20(c)]
Additionally, your products are misbranded within the meaning of Section 502(o) in that your devices are manufactured in an establishment not duly registered under Section 510, and they are not included in a list required by Section 510(j) of the Act.
We have received your November 22, and December 30, 2005 written responses to the FDA-483, Inspectional Observations, issued at the conclusion of the inspection. While you state that you have initiated or completed corrective action for several items, your response does not fully address all our concerns. For example, you state that a Device Master Record has been written for four products (Observation 10), but these were not submitted with the response to allow a review and confirmation of adequacy. Additionally, our investigators documented that 26 of 34 complaints did not contain documentation of the investigation of the root cause(s). Your response states that you have taken action to assure that complete investigation and documentation is generated going forward, but you do not address the situation for the deficiency noted (Observation 1) during our inspection. Please submit documentation as to the steps taken, including root cause(s) and all corrective actions for these complaints.
We have also received your January 26 and January 30, 2006 written responses. The documentation submitted with these responses indicates that you have essentially documented your prior complaints on your new complaint form. While this is one step towards the investigation and documentation of the root causes, the more important action is to evaluate the complaints for trends with types of complaints, common equipment and/or common employees and to use the conclusions as the basis for remedial action.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of human medical devices, you are responsible for assuring that your overall operations and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations and to establish procedures to prevent their recurrence . Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. Other Federal Agencies are informed about the Warning Letters issued so they may consider this information when awarding government contracts for medical device products.
You should 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 each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. Also include copies of any available documentation demonstrating that corrections have been made. If you have any questions or need clarification regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.
Your reply should be directed to:
Pamela B. Schweikert
Director, Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92612
Alonza E. Cruse