Inspections, Compliance, Enforcement, and Criminal Investigations
Wisconsin Aluminum Foundry Co 5/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
May 12, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 27
Phillip L. Jacobs
Chief Executive Officer
Wisconsin Aluminum Foundry Co.
1931 South 14th Street
Manitowoc, Wisconsin 54220-5004
Dear Mr. Jacobs:
During an inspection of your firm located in Manitowoc, Wisconsin, on March 3, 2011, investigators from the Food and Drug Administration (FDA) determined that your firm manufactures steam sterilizers. 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 function of the body.
This inspection revealed that these devices 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 Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Joel Andrew, General Manager, dated March 21, 2011, concerning our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations, which was issued to Mr. Andrew. We address this response below. Violations include, but are not limited to, the following:
1. Failure to maintain a Device Master Record as required by 21 CFR 820.181. For example, you did not have a Device Master Record which included, or referred to the location of, device specifications or procedures for production and quality assurance.
2. Failure to maintain Device History Records, which is a requirement of 21 CFR 820.184. For example, you did not maintain records of device assembly or acceptance testing.
3. Failure to establish procedures for finished device acceptance as required by 21 CFR 820.80(d). For example, you did not have written procedures for finished device testing including instructions for how to document testing.
4. Failure to establish procedures for acceptance of incoming product, which is required by 21 CFR 820.80(b). For example, you did not have written procedures for incoming inspection including instructions for how to document testing.
5. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). For example, your Procedure No. 126.96.36.199, Customer Complaint and Returns, was in draft form and had not been implemented.
6. Failure to review and evaluate complaints to determine whether an investigation is necessary, which is required by 21 CFR 820.198(b). For example, complaints 2110137 (leaking), 2110145 (problem with sterilizer), and 2110091 (defective), were not reviewed, evaluated, and investigated.
7. Failure to establish adequate procedures to control product that does not conform to specified requirements, which is required by 21 CFR 820.90(a). For example, your Procedure No. 188.8.131.52, Non Conforming Material, had not been fully implemented, and a Nonconforming Material Report was in draft form.
The March 21, 2011, response to the Form 483 did not provide enough information for us to fully assess your corrective actions. Documentation of corrections (e.g., revised procedures and forms) was not provided. A follow-up inspection will be necessary to assess whether your corrective actions are complete and fully implemented.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Also, 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within 15 working days from the date you receive this letter. Provide an update on 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 actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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. If you have any questions about the content of this letter, please contact Mr. Philips at (612) 758-7133.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close-out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Gerald J. Berg