# FDA 483 - Associates of Cape Cod, Inc. - November 08, 2018

Source: https://www.keypedia.com/records/483/associates-of-cape-cod-inc/3a0b3a27-f82f-4cac-855d-71d76d47719c

> FDA 483 for Associates of Cape Cod, Inc. on November 08, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Associates of Cape Cod, Inc.
- Inspection Date: 2018-11-08
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Associates of Cape Cod, Inc., an IVD manufacturer in East Falmouth, MA, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate procedures for non-conforming product, environmental controls, process validation, complaint handling, and maintaining sanitary storage conditions. These issues indicate a lack of robust quality system controls across several critical manufacturing and storage operations.

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## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

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