Inspections, Compliance, Enforcement, and Criminal Investigations
Wallach Surgical Devices, Inc. 03-Aug-06
Department of Health and Human Services
Public Health Service
New England District
VIA FEDERAL EXPRESS
August 3, 2006
Mr. Ronald M. Wallach
President / CEO
Wallach Surgical Devices, Inc.
235 Edison Road
Orange, CT 06477
Dear Mr. Wallach:
The Food and Drug Administration (FDA) recently performed an inspection on June 6 through June 9, 2006 of your medical device manufacturing facility located at 235 Edison Road, Orange, CT. This inspection covered the Endocell Endometrial Cell sampler, the Inseminator Catheter and the LL100 Cryosurgical system. Under a United States law, the Federal Food, Drug and Cosmetic Act (the Act), all of these above-mentioned products are considered to be medical 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.
The recent FDA inspection found that the devices manufactured at your facility are adulterated under 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, the manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21 Code of Federal Regulations, (21 CFR), Part 820. FDA has found ongoing systemic violations in the quality management system employed to ensure the safety and effectiveness of the medical devices you distribute . Significant deviations from the QS regulations include, but are not limited to, the following:
1. Failure to adequately validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example, on a number of occasions, your firm has resterilized medical devices without performing any functional testing to assure that the ETO resterilization process did not compromise the device or the packaging.
2. Failure to ensure that each lot of finished device meets its acceptance criteria prior to its release for final distribution, as required by 21 CFR 820.80(d)(1). For example, products which had been through the sterilization process were released for distribution, sold and shipped to customers prior to receiving sterility results. During the inspection, you indicated that there were times when a customer is really in need of product. You should be aware that this regulation is in place to assure that only devices which meet all of their finished device requirements are allowed to be released.
a. On March 6, 2006, you sold and distributed medical devices, specifically, intrauterine sounds, lot #082006, that was part of a sterilization load #R060227-06. The sterility results for this sterilization load were not completed until March 9, 2006.
b. On February 2, 2006, you sold and distributed your medical devices, specifically disposable tubing, lot #122005, that was part of a sterilization load #R060124-04. The sterility results for this sterilization load were not completed until February 7, 2006.
3 . Failure to establish and maintain procedures to ensure that all received product conforms to specified reQUirements as required by 21 CFR 820.50. For example, your firm was receiving [redacted] Catheters that were labeled, "For veterinary use only. Not for human use. Your firm packaged these products in your own packages labeled,"WALLACH *** The Inseminator *** Intrauterine Inseminator *** Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician" and distributed them to customers. There are no procedures for evaluating incoming product labeled for veterinary use to ensure that it meets all applicable specifications for use in humans.
4. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20. For example, your firm has allowed the shipment, on at least two occasions, of medical devices for which you had not yet received appropriate sterility results.
We are in receipt of your letter dated June 28, 2006 which was in response to the Form FDA 483 that was issued to your facility on June 9, 2006. We acknowledge your general commitments to certain FDA 483 items. However, your response fails to address specific system-wide corrective actions that are necessary to bring your firm into compliance. Moreover, your response by itself is inadequate to address the observations because you must properly implement, document, and maintain each corrective action to ensure its effectiveness. Further, we cannot determine whether the procedures you have promised are adequate without reviewing the documentation. We would appreciate receiving copies of the documentation of all the revised procedures that you have discussed.
This letter is not intended to be an all-inclusive list of deficiencies at the above listed facilities. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the conclusion of the inspection indicate continued serious underlying problems in your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts. Additionally, no premarket submissions for Class III devices to which the Quality System/Current Good Manufacturing Practice deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
It is necessary to take action on this matter now. Please let this office know in writing, within fifteen (15) working days from the date you received this letter, what additional steps you have taken since your letter of June 28, 2006 to correct the problems discussed above. To the extent not already addressed, we also ask that you explain how you plan to prevent these violations from happening again.
In order to facilitate FDA in making the determination that such corrections have been made, we are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirement of the device Quality System regulations (21 CFR Part 820). You should also submit a copy of the consultant's report and certification by yourself that you have reviewed the consultant' s report and that your establishment has initiated or completed all corrections called for in the report.
The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
1. Initial certifications by consultant and establishment-September 2006;
2. Subsequent certifications - March 2007 and
3. Subsequent certifications - September 2007.
Please direct your response or any questions you may have to Karen Archdeacon, Compliance officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. Her telephone number is (781) 596-7707; FAX No. 781-596-7899.
Gail T. Costello
New England District