Inspections, Compliance, Enforcement, and Criminal Investigations
Ad-Tech Medical Instrument Corporation 4/12/12
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
April 12, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 33
David A. Putz
President and Owner
Ad-Tech Medical Instrument Corporation
1901 William Street
Racine, Wisconsin 53404
Dear Mr. Putz:
During an inspection of your firm, Ad-Tech Medical Instrument Corporation, located at 1901 William Street, Racine, Wisconsin, on December 13, 2011, through January 11, 2012, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures devices for neurological monitoring and neurosurgery. 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 responses from your firm dated February 1, March 5, and March 30, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, issued on January 11, 2012, to Lisa A. Theama, Executive Vice President. We address those responses below. Violations include, but are not limited to, the following:
1. Failure to establish adequate procedures for design change as required by 21 CFR 820.30(i). Specifically:
A. A change identified as “(b)(4)” was made to the design of (b)(4) to use (b)(4). The procedures for making this change (“Product Development Protocol Operating Procedure,” ENGR-2000, “Design Verification Work Instruction,” ENGR-3001, and “Design Validation Work Instruction,” ENGR-3002) were not followed. For example:
i. There was no evidence to support an update of the “Design Development Planning Checklist” to maintain the Project Plan, as required by ENGR-2000.
ii. There was no evidence to support Design Verification activities were performed to confirm design inputs were met by design outputs, per ENGR-2000. A Design Verification Plan and Report do not exist, which is required by procedure ENGR-3001.
iii. The “Design Validation Work Instruction,” ENGR-3002, step (b)(4) requires: a rationale to explain the need for validation; the identification of equipment to be used during the validation; a detailed description of the steps to follow in the validation; a sample size; materials; test method; and acceptance criteria. The “(b)(4) Validation Plan” and “(b)(4) IQ, OQ, PQ” do not include these required elements.
iv. There was no documented review and approval of the “(b)(4) Master Validation Plan” and “(b)(4) IQ, OQ, PQ.” Also, there was no record of production of the validation test units and no raw data to support the testing.
B. A change identified as “ECN 3434” was made to the (b)(4) in response to a second complaint, 2055C, regarding an anchor bolt breaking during a surgical procedure. The procedures, “Document and Data Conventions Operating Procedure,” DOCU-2000, Rev. R, “Change Control Work Instruction,” DOCU-3003, Rev. M, and “Engineering Change Notice,” DOCU-4002, Rev. O were not followed for making this change.
i. (b)(4) analysis of the change was not performed by Engineering, Marketing, Production, and Regulatory as required by procedure DOCU-4002, Rev. O.
ii. The “Hazard Identification - Placement and Accessories,” RMF-4005-2, Rev. C, and the “Risk Analysis & Control…,” RMF-4005-3, Rev. E, were not updated to address the hazard of the anchor bolt(s) breaking during use by a physician (b)(4), per DOCU-2000, DOCU-3003, and DOCU-4002.
iii. There is no evidence of verification and/or validation of (b)(4) changes prior to implementation. Justification for not verifying or validating the change does not exist.
iv. The Product Specification, SPEC-3186, and Bill of Materials were not updated to reflect the specification changes, per DOCU-3003.
2. Failure to establish adequate procedures for design review as required by 21 CFR 820.30(e). Specifically, the design project “(b)(4)” was not reviewed and approved according to procedure “Product Development Protocol Operating Procedure,” ENGR-2000. For example:
A. The date of the Phase (b)(4) Design Review meeting is not documented.
B. The “Phase (b)(4)” documents a Phase (b)(4) Start Date of 11/1/11; however the “Date of Phase (b)(4) Review Meeting” is recorded as 10/27/11.
C. There were no records to show that the “Design Development & Planning Checklist” was updated, reviewed, and approved as the design and development evolved. A copy of the updated checklist was not attached to the records of design review.
D. There is no record of who fulfilled the role of “Independent Evaluator” as required by ENGR-2000.
3. Failure to adequately document and approve process validation activities and results, which is required by 21 CFR 820.75(a). Specifically, the procedure “Process and Equipment Validation Work Instruction,” PROD-3072, Rev. A, was not followed for changes made to (b)(4) to address repetitive nonconformances of “(b)(4)” described in Corrective Action Report (CAR) 0179. For example:
A. The “(b)(4) Validation Plan/(b)(4) Validation Report” does not include the required elements described in PROD-3072 such as: the rationale for the validation; the equipment to be used; a detailed description of the steps to follow in the validation; materials; test method; and acceptance criteria.
B. There is no record of the production of the test units. The plan/report is not dated, and the author of the plan/report is not documented.
C. Actual test results (i.e., raw data) were not documented for the (b)(4) samples each of (b)(4) that were run by (b)(4) operators. Also, there is no record of which operators performed the work.
D. Data summaries, as required by PROD-3072, step (b)(4), were not included with the plan/report. The procedure requires the data summaries to explain how the data meets the individual requirements in the validation plan.
E. There was no documented review and approval of the “(b)(4) Validation Plan/(b)(4) Validation Report.”
4. Failure to establish adequate procedures for corrective and preventive action as required by 21 CFR 820.100(a). Specifically, the corrective actions taken in response to CAR 0179 were not effectively implemented. For example, validation was not conducted according to established procedures (as noted in #3 above). Also, (b)(4) Maintenance Procedure, QUAL-3057, created as part of the corrective action, references a form (QUAL-4045 “(b)(4)”) which was not being used. Instead, an uncontrolled document “(b)(4)” was being used.
5. Failure to establish adequate procedures for rework of nonconforming product, which is required by 21 CFR 820.90(b)(2). Specifically, nonconforming Macro-Micro Depth Electrodes (the subject of Complaint 2077C), were returned to Ad-Tech and repaired; however, there is no record of final electrical test results to demonstrate specifications were met prior to returning the device to the customer. “Rework/Repair of Product Work Instruction,” PROD-3083, Rev. E, requires completion of “Inspection Testing Results,” QUAL-4051 after repair.
6. Failure to establish adequate procedures for changes to a specification and procedure as required by 21 CFR 820.70(b). For example, PROD-3093, Rev. K, “(b)(4) Work Instructions,” contained a part number (b)(4) that is not used in those assemblies. Also, PROD-3093, Rev. K, did not include (b)(4) instructions for the (b)(4)s. PROD-3093, Rev. M, did not include the instructions for the (b)(4) assembly.
7. Failure to establish adequate procedures to control product that does not conform to specified requirements, which is a requirement of 21 CFR 820.90(a). Specifically, there was no documented determination of the need for an investigation for nonconforming Material Report 9614 initiated on August 24, 2011, for a (b)(4). The procedure “Control of Nonconforming Product Operating Procedures,” QUAL-2003, Rev. M, step (b)(4), states that “(b)(4).”
We reviewed the Form 483 responses dated February 1, March 5, and March 30, 2012, concerning the above-noted violations of the Quality System regulation, 21 CFR 820. Some of your corrective actions, such as your “FDA Excellence in 2012” program, have not yet been completed. For corrective actions that have been completed, a follow-up inspection will be necessary to fully assess implementation and effectiveness.
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, with an update on the status of the specific steps you have taken to correct the violations cited in this Warning Letter. Include an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Please provide 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, at the address on this letterhead. 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 to bring your products into compliance.
Joann M. Givens