# FDA 483 - Associates of Cape Cod, Inc. - November 26, 2019

Source: https://www.keypedia.com/records/483/associates-of-cape-cod-inc/3d8e8689-ca46-4872-9b44-1ced3f9c8cf8

> FDA 483 for Associates of Cape Cod, Inc. on November 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Associates of Cape Cod, Inc.
- Inspection Date: 2019-11-26
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Associates of Cape Cod, Inc., a contract testing laboratory in East Falmouth, MA, was cited for significant deficiencies in laboratory record retention and quality unit procedures during an FDA inspection. The firm failed to retain complete testing data and did not adequately review and approve investigations within established timeframes. These issues indicate a lack of adherence to good manufacturing practices regarding data integrity and quality system oversight.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/associates-of-cape-cod-inc/c3c3c25d-3eec-4ab0-826d-a9c915ae89d2

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94