# FDA 483 - Pharmco Laboratories Inc. - March 20, 2025

Source: https://www.keypedia.com/records/483/pharmco-laboratories-inc/307f08c1-f02f-4e7c-a0f8-9ee4b7257176

> FDA 483 for Pharmco Laboratories Inc. on March 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmco Laboratories Inc.
- Inspection Date: 2025-03-20
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pharmco Laboratories Inc., a contract manufacturer of human drug products in Titusville, FL, was cited for significant deficiencies across multiple areas of its operations. The inspection revealed critical issues including uninvestigated out-of-specification microbiology results for the water system, inadequate laboratory controls, and poorly designed and maintained equipment. These findings indicate a systemic failure to adhere to cGMP regulations, with several observations being repeats from prior inspections.

## Related Documents

- [WARNING_LETTER - 2015-11-30](https://www.keypedia.com/records/warning_letter/pharmco-laboratories-inc/3aa59e48-cc9c-4f3a-94fa-ce2146b19b61)
- [483 - 2021-09-22](https://www.keypedia.com/records/483/pharmco-laboratories-inc/8047a27a-811d-40be-8578-1acbe1e7ba66)
- [483 - 2025-03-20](https://www.keypedia.com/records/483/pharmco-laboratories-inc/6c7b362b-b600-42df-b453-a4c801cb4bed)

## Related Officers

- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Michael Z. Weigman](https://www.keypedia.com/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)

Company: https://www.keypedia.com/companies/pharmco-laboratories-inc/b34e3481-0ea5-433a-9e03-ce66b44df443

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6