Inspections, Compliance, Enforcement, and Criminal Investigations
Norland, A Cooper Surgical Company 1/4/12
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
January 4, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 19
Nicholas J. Pichotta
Chief Executive Officer
Cooper Surgical, Inc.
95 Corporate Drive
Trumbull, Connecticut 06611
Dear Mr. Pichotta:
During an inspection of your firm, Norland, A Cooper Surgical Company, located at W6340 Hackbarth Road, Fort Atkinson, Wisconsin, on August 30 through September 13, 2011, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures bone densitometers. 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 (21 CFR), Part 820. We received a response from you dated October 3, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (Form 483), issued to Pamela S. Holler, General Manager, on September 13, 2011. We address your response below. Violations include, but are not limited to, the following:
1. Failure to establish adequate procedures for design changes as required by 21 CFR 820.30(i). Specifically, an Engineering Change Notice (ECN) was not completed for a (b)(4)procedure (b)(4)”) that was developed and distributed to two customers to address a software defect that could result in improper archiving of scan results into the wrong patient’s record. The procedure provided instructions to follow to ensure proper archiving of scan results. Your Engineering Change Notice (ECN) Procedure, BSR-ENG-002, Rev. S, requires that such changes be processed and approved following the ECN procedure. There was also no documentation of verification or validation of the “(b)(4) procedure prior to implementation and distribution.
2. Failure to adequately review and evaluate complaints to determine whether an investigation is necessary as required by 21 CFR 820.198(b). Specifically, five of eight complaints reviewed during the inspection had not been evaluated by your firm to determine whether an investigation was necessary. These complaints (listed below) alleged deficiencies or problems with your devices.
Complaint Number Date Received
3. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, which is required by 21 CFR 820.198(a). Specifically, Product Complaint Reports 683 and 1129 reported problems with multiple devices/serial numbers, but these additional reports were not processed as separate complaints. As a result, queries for potential trends, as required by steps (b)(4) of Complaint Procedure, BSR-QAR-003, Rev. O, would be incomplete.
Our inspection also revealed that your DXA Bone Densitometers are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Reports of Corrections and Removals regulation.
Your firm failed to report the required information regarding a device correction and removal action to FDA within 10 days of initiating the correction or removal, which is required by 21 CFR 806.10(b). Specifically, a (b)(4) procedure (“(b)(4)”) was developed and distributed to two customers to address a software defect that could result in improper archiving of scan results into the wrong patient’s record. This correction was initiated on or about June 20, 2011; however, your firm did not notify FDA of the correction until September 23, 2011, subsequent to the August 30 through September 13, 2011, inspection. When you notified FDA on September 23, 2011, your firm had expanded the correction to inform all customers who had received (b)(4)
We reviewed your Form 483 response dated October 3, 2011, and we offer the following comments:
o With regard to #1 above, please provide a copy of your revised Technical Support Procedure, SOP-SERV-042. In addition, provide documentation of the verification and/or validation of the (b)(4) procedure (“(b)(4)”).
o Regarding #2 above, please provide copies of the updated complaints (951, 1008, 1009, 1129, and 1216) and a copy of the revised complaint procedure, BSR-QAR-003.
o Regarding #3 above, please provide copies of the complaints generated for the additional devices/serial numbers identified in complaints 683 and 1129.
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, 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.
Anthony L. Nicoli