Inspections, Compliance, Enforcement, and Criminal Investigations
Unipower Corporation 18-Oct-07
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 18, 2007
RETURN RECEIPT REQUESTED
Refer to MIN 08-02
Robert J. Welsch
President and Owner
1216 West 96th Street
Bloomington, Minnesota 55431
Dear Mr. Welsch:
During an inspection of your firm located in Bloomington, MN, on August 28, 29, and 31, 2007, an investigator from the Food and Drug Admiriistration (FDA) determined that your firm manufactures batteries that are used in medical devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are 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 any function of the body.
The majority of the batteries manufactured by your firm are distributed to hospitals and other end-users as replacement batteries: FDA considers replacement batteries to be accessory devices as defined in Title 21, Code of Federal Regulations, Part 807, Section 20(a)(5),[21 CFR 807.20(a)(5)]. An accessory to a medical device is considered a finished device and must comply with the Current Good Manufacturing Practice(CGMP) requirements of the Quaiity System (QS) regulation found at 21 CFR 820.
The aforementioned inspection revealed that your replacement batteries are adulterated within the meaning of 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, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice(CGMP) requirements of the Quality System (QS) regulation found at 21 CFR 820. Violations include, but are not limited to the following:
1. Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization as required by 21 CFR 820.20. Specifically, your firm has not established and implemented a quality policy and objectives [21 CFR 820.20(a)], procedures for management review [21 CFR 820.20(c)], and a quality plan [21 CFR 820.20(d)].
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198(a).
3. Failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet its specifications, which is required by 21 CFR 820.198(c). Specifically, your firm failed to conduct an investigation into over 250 failures of batteries that were still under warranty. These complaints include (for example) batteries that caught fire, blew up, won't charge, or are leaking.
4. Failure to establish procedures for corrective and preventive action activities, which is required by 21 CFR 820.100(a).
5. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a). Specifically, there was no documentation that calibration and maintenance has been done on voltage meters since the previous FDA inspection in August 2002.
6. Failure to establish procedures for addressing the identification, documentation, evaluation, segregation, disposition, and investigation of nonconforming product, which is required by 21 CFR 820.90(a). Specifically, your firm has not developed procedures to identify and evaluate nonconforming product from, receiving through manufacturing and final testing of batteries.
7. Failure to document employee training, which is required by 21 CFR 820.25(b). Specifically, your firm has no documented training for any of the employees involved in the manufacturing of medical batteries.
8. Failure to establish procedures for conducting quality audits as required by 21 CFR 820.22. Also, no quality audits have been conducted.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure compliance with the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. 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 to bring your products into compliance.
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. Additionally, no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
You should take prompt action to correct the deviations described in this letter. 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 money penalties.
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead.
H. Tom Warwick
(for) W. Charles Becoat