# FDA 483 - Ferndale Laboratories, Inc. - February 27, 2026

Source: https://www.keypedia.com/records/483/ferndale-laboratories-inc/a65d3b06-f9bd-4af7-b9b1-ee62e9f47189

> FDA 483 for Ferndale Laboratories, Inc. on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ferndale Laboratories, Inc.
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Ferndale Laboratories, Inc. in Ferndale, MI, from February 23-27, 2026, revealed a significant quality control deficiency. The firm failed to verify the identity of each component of drug products by not conducting identity tests on all containers of a raw material used in manufacturing. This lapse led to the release and shipment of drug products made with unverified components.

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- [483 - 2022-03-04](https://www.keypedia.com/records/483/ferndale-laboratories-inc/ab9a750b-a659-4524-8158-b7f3a1761c79)
- [EIR - 2022-03-04](https://www.keypedia.com/records/eir/ferndale-laboratories-inc/0c464a44-7aaf-474e-933a-a0e4e4054cf1)

## Related Officers

- [Ramia Brzenjy](https://www.keypedia.com/people/ramia-brzenjy/b0e5e3b0-c295-4ec6-845a-95968824c16a)
- [Shannon L. Maisano](https://www.keypedia.com/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)

Company: https://www.keypedia.com/companies/ferndale-laboratories-inc/0c6013f2-a6e7-41ff-a461-1e3fda056678

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3