# FDA WARNING_LETTER - Norland, A Cooper Surgical Company - September 13, 2011

Source: https://www.keypedia.com/records/warning_letter/norland-a-cooper-surgical-company/715c1474-574a-41bc-9486-89f8c1754bd1

> FDA WARNING_LETTER for Norland, A Cooper Surgical Company on September 13, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Norland, A Cooper Surgical Company
- Inspection Date: 2011-09-13
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On January 4, 2012, the FDA issued a Warning Letter to Norland, A Cooper Surgical Company, following an inspection from August 30 to September 13, 2011. The inspection found that the firm's bone densitometers, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish adequate procedures for design changes (21 CFR 820.30(i))**: An Engineering Change Notice (ECN) was not completed for a procedure distributed to customers to address a software defect causing improper archiving of scan results. There was also no documentation of verification or validation for this procedure.
2.  **Failure to adequately review and evaluate complaints (21 CFR 820.198(b))**: Five of eight complaints reviewed were not evaluated to determine if an investigation was necessary.
3.  **Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a))**: Product Complaint Reports 683 and 1129, which reported problems with multiple devices, were not processed as separate complaints,

## Related Officers

- [Pamela S. Holler](https://www.keypedia.com/people/pamela-s-holler/574f9c4a-50fa-4380-8d0d-2f7c362a8d05)
- [Management Analyst](https://www.keypedia.com/people/anthony-l-nicoli/6ceff13c-8f46-4314-883f-69907790e76f)
- [Timothy G. Philips](https://www.keypedia.com/people/timothy-g-philips/ab522f00-8e56-42e4-92b6-55d5f1a4a65b)

Company: https://www.keypedia.com/companies/norland-a-cooper-surgical-company/e8116ce3-9f34-4f2c-b1b4-fcfcf417ca6b

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861