Inspections, Compliance, Enforcement, and Criminal Investigations
Biomedicare, Inc. 19-Jun-07
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
June 19, 2007
Eun Kyung Sohn
Vice President/General Manager
6761 Katella Ave.
Cypress, CA 90630
Dear Ms. Sohn:
We are writing to you because between March 8 and 21, 2007, an inspection of your facility located in Cypress, California, conducted by our investigator revealed serious regulatory problems involving your dental implants.
Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 321h, these dental implants are considered to be medical devices because they are used to diagnose or treat a medical condition. The Act requires that manufacturers of medical devices obtain marketing clearance for their products from FDA before they may be offered for sale. Failure to obtain pre-market clearance renders your device adulterated pursuant to 501(f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), and misbranded pursuant to 502(o) of the Act, 21 U.S.C. § 352(o), unless your firm has an investigational device exemption. Once marketing clearance is obtained products must conform to the approved application.
Under section 501(h) of the Act, 21 U.S.C. § 351(h), manufacturers of medical devices are required to comply with Current Quality Systems Regulations (QSR) for medical devices (Title 21, Code of Federal Regulations (C.F.R.), Part 820); deviations from these regulations cause medical devices distributed by your firm to be adulterated within the meaning of the Act.
Our inspection found the following device QSR deficiencies:
1. Complaint handling procedures have not been defined to ensure that all complaints are adequately evaluated and documented, or that they are processed in a uniform and timely manner. Specifically, your complaint files are incomplete, investigations are incomplete and in some cases not performed at all, and some complaints have no documentation of activity for 5 or 6 months after receipt. [21 C.F.R. § 820.198]
2. A process where the results cannot be fully verified by subsequent inspection and test has not been fully validated and approved according to established procedures. Specifically, you have not validated your sterilization process nor have you validated your clean room used to package finished devices. [21 C.F.R. § 820.75(a)]
We have received and reviewed your written responses dated April 6 and May 3, 2007, to the FDA-483, List of Inspectional Observations that was issued at the conclusion of the inspection. While your responses indicate that you have implemented some written procedures, it does not provide a comprehensive response to the status of reported deviations nor does it address future occurrences.
We remain very concerned about your complaint and MDR handling practices. Timeliness is of utmost importance as facts become harder to recall and data becomes more difficult to locate as time passes. QSRs require timely follow-up to complaints and filing of MDRs so as to maximize the information that can be obtained. This information is then reviewed, analyzed, and trended by the firm, thereby facilitating the ability to adjust procedures accordingly or correct for deviations before problems get out of control. Incomplete data makes conducting comprehensive investigations and forming accurate conclusions all but impossible, thereby undermining the very purpose of the regulations. The MDR reporting date you should use is the date your firm completes the Medwatch form, regardless of how much time has lapsed.
Additionally, your assertion concerning the lack of exigency regarding the validation of your sterilization cycle does not take into consideration the speciation of microorganisms in the bioburden unique to your facility and manufacturing processes. Although you have some very limited bioburden data, the usefulness of this information in determining the adequacy of your sterilization cycle is unsound at best.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of 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 violations may result in further regulatory action such as seizure, injunction, civil money penalties, and/or FDA recall. Other federal agencies are informed about the Warning Letters issued by FDA 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