Inspections, Compliance, Enforcement, and Criminal Investigations
C & E GP Specialists 12-May-05
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
May 12, 2005
Harvey Yamamoto, O.C.
C & E GP Specialists
1015 Calle Amanecer
San Clemente, CA 92673
Dear Dr. Yamamoto:
Your firm manufactures medical devices. During an inspection of your manufacturing facility located in San Clemente, California, conducted between January 26 and February 8, 2005, our investigator 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") (21 U.S.C. 351(h)).
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 have received 12 complaints concerning hooks on the edges of your lenses, poor optics, poor performance and/or defective edges or lenses. Eleven of these complaints have performance no documentation of an 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 complaint and returned goods data lacking documentation of any investigation. [21 CFR 820.100(a)(1)]
3. You have not documented corrective and/or preventive action needed to prevent the recurrence of nonconforming product or other quality issues. Specifically, you have no documentation to support any corrective and/or preventive action to address nonconforming or other quality issues which led to the receipt of 12 complaints. [21 CFR 820.100(b)]
4. You have not established, defined and documented corrective and preventive action procedures. [21 CFR 820.100(a), (b)]
5. Your quality audit procedure is incomplete. Specifically, you have not identified a responsible individual to conduct the audit, areas to be covered, individual(s) responsible for review, implementation of any corrective action, and informing management. [21 CFR 820.22]
6. You have not documented acceptance activities. Specifically, for at least 3 invoices the device history records do not contain the original processing parameters as ordered by the consignee. [21 CFR 820.80(e)]
7.You released for distribution finished product without the signature of the individual designated to authorize such release. Specifically, at least 3 invoices with product identified in your complaint documentation had product released without the signature of an authorized official. [21 CFR 820.80(d)(3)]
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. In addition, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
We are in receipt of your February 22, and March 28, 2005 responses to the Form FDA 483, Inspectional Observations, issued to you at the close of the most recent inspection. While your response commits to correction of your documentation, your response is silent as to any corrective action planned to address the lack of a thorough investigation of complaints and returned goods to determine if additional product may be adulterated and/or if a root cause of quality rejects can be identified. While written procedures are required, it is of far greater importance that appropriate action be taken with respect to any and all potential quality issues. You should provide written commitment of your planned actions with respect to investigation of returned goods, complaints and other potential quality concern data sources.
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