Ad-Tech Medical Instrument Corporation 11/14/13
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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
November 14, 2013
Via UPS Overnight Delivery
Refer to MIN 14 – 01
David A. Putz
President and Chief Executive Officer
Ad-Tech Medical Instrument Corporation
1901 William Street
Racine, Wisconsin 53404
Dear Mr. Putz:
During an inspection of your firm located in Racine, Wisconsin, on April 17 through June 5, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Subdural and Depth Electrodes. 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 to affect the structure or any 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (21 CFR), Part 820. We received your responses dated June 24 and August 12, 2013, concerning our investigator’s observations noted on the Form FDA-483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for design changes, as required by 21 CFR 820.30(i).
Specifically, your firm failed to follow the “Product Development Protocol Operating Procedure/Product Design & Development” (ENGR-2000), which states “The Product Development Protocol (PDP) for new products or major revisions to existing designs consists of (b)(4) main phases***Significant changes***would require design controls per this procedure.” The (b)(4) main phases include the following: (b)(4). There was no documented evidence to support the (b)(4) phases being followed or design controls being applied for the major revisions and/or significant changes as follows:
- Combination electrodes which include depth and subdural electrodes;
- Subdural electrodes to include macro-micro contacts;
- Subdural electrodes to include up to (b)(4) contacts;
- Subdural electrodes which include specifications that fall outside the boundaries of the 510(k) for subdural electrodes.
2. Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).
Specifically, the “Recalls, Recoveries and Field Corrections Work Instruction” (REGU-3002) requires a “Corrective Action Request” to be generated within five working days after your firm becomes aware of an incident, which prompted a recall. Your firm initiated a recall of your Macro-Micro Subdural Electrodes on December 18, 2012 (subsequently classified as a Class I recall). However, your firm failed to generate a Corrective Action Request.
We have reviewed your responses dated June 24 and August 12, 2013. We acknowledge your commitment to addressing your design control and CAPA procedures; however, the implementation of your corrective actions will require verification during our next inspection.
In addition, you have clearance for Subdural Electrodes via K053363, Depth Electrodes via K053358, and Macro-Micro Depth Electrodes via K041604. Your firm has since made modifications to your cleared electrodes such as the subdural electrodes with macro-micro contacts. FDA reviewed and determined that these modifications are significant with respect to your original premarket clearance submissions and may change the design or performance and/or affect the safety and efficacy of the devices.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to Melissa I. Michurski, Compliance Officer, at the address on the letterhead. If you have any questions about the content of this letter, please contact Ms. Michurski at (612) 758-7185.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt action to correct the violations and bring the products into compliance.
Michael Dutcher, DVM