# FDA 483 - Ferndale Laboratories, Inc. - March 04, 2022

Source: https://www.keypedia.com/records/483/ferndale-laboratories-inc/ab9a750b-a659-4524-8158-b7f3a1761c79

> FDA 483 for Ferndale Laboratories, Inc. on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ferndale Laboratories, Inc.
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Ferndale Laboratories, Inc., a manufacturer in Ferndale, MI, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in the quality control unit's authority to conduct full investigations, a failure to thoroughly review unexplained discrepancies and out-of-specification results for drug products and excipients, and a lack of written procedures to prevent objectionable microorganisms in non-sterile drug products. These issues indicate a need for improved quality system oversight and investigation practices.

## Related Officers

- [Courtney E. Hillier](https://www.keypedia.com/people/courtney-e-hillier/4bb6ba54-896a-4296-a4ea-81d8801fdc2f)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0