Inspections, Compliance, Enforcement, and Criminal Investigations
In Vivo Metric Systems Corporation 17-Mar-06
Department of Health and Human Services
Public Health Service
San Francisco District
Via Federal Express
March 17, 2006
Benny S . Piraino, President
In Vivo Metric Systems Corporation
1440 Grove Street
Healdsburg, CA 95448
Dear Mr. Piraino:
During an inspection of your establishment conducted from September 13, 2005 through September 30, 2005 our investigators determined that your firm is engaged in operations subject to the requirements of 21 Code of Federal Regulations 820 (21 CFR 820). Our inspection revealed that your facility manufacturers cutaneous electrodes. The articles are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The devices manufactured by your firm are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C.351), in that the methods used in, or the facilities or controls used for their manufacturing, packing, storage, or installation are not in conformance with the Good Manufacturing Practice (GMP) requirements of the Quality System (QS) Regulations for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 830. Significant deviations include, but are not limited to the following:
1. Failure to define, document and implement procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22. Specifically, your quality audit procedures and audits are limited to inspection of the manufacturing equipment and fail to include an audit of other quality subsystems such as design controls, production and process controls, management controls, and corrective and preventive actions.
2. Failure to establish procedures for implementing corrective and preventive actions as required by 21 CFR 820.100(a) and to document such procedures as required by 21 CFR 820.100(b). Specifically, you failed to document corrective actions taken such as increasing the amount of [redacted] and you failed to verify or validate that this corrective action was effective.
3. Failure to validate with a high degree of assurance a process that cannot be fully verified by subsequent inspection and test as required by 21 CFR 820.75(a). Specifically, you have failed to validate the sterilization process recommended in the labeling of your cutaneous electrodes.
4. Failure of the device master record for the cutaneous electrode to include, or refer to the location of, the device specifications including appropriate drawings, composition, formulating, component specifications as required by 21 CFR 820.181(a). Specifically, your device master record fails to include the specifications for the [redacted], and the [redacted]
5. Failure to establish and maintain procedures to ensure that device history records demonstrate that the device is manufactured in accordance with the Device Master Record as required by 21 CFR 820.184. Specifically, your Device History Records fail to include the dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records and labeling for the device.
6. Failure to fully document your acceptance activities as required by 21 CFR 820.80(e). Specifically, your acceptance records for visual and continuity tests performed on the cutaneous electrode fail to include the acceptance activities performed, the dates acceptance activities are performed, the results, and the signature of the individual conducting the acceptance activities.
7. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under the Medical Device Reporting requirements as required by 21 CFR 820.198(a)(3). Specifically, the IVM Procedure for Handling Complaints dated 12/10/1987 does not describe how complaints will be evaluated to determine whether they should be filed as a Medical Device Report under 21 CFR Part 803.
8. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50, in that your firm has no procedures to control purchased of lead wire and silver-silver chloride compounds.
In addition, your cutaneous electrodes are adulterated within the meaning of 501(e0(1) in that your device fails to conform to a performance standard established under section 514 of the Act. Specifically, your cutaneous electrodes fail to conform to the performance Standards for Electrode Lead Wires and Patient Cables, 21 CFR 898. Our inspection documented that you are distributing electrodes that fail to comply with sub clause 56.3(c) of the International Electrotechnical Commission (IEC) 601-1: Medical Electrical Equipment as required by 21 CFR 898.12(a) in that the [redacted].
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. 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.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Please address your response and any questions to the Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502, attention: Russell A. Campbell, Compliance Officer.
Barbara J. Cassens