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

Source: https://www.globalkeysolutions.net/records/483/pharmco-laboratories-inc/6c7b362b-b600-42df-b453-a4c801cb4bed

> 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: Florida District Office
- Summary: Pharmco Laboratories Inc. in Titusville, FL, a contract manufacturer of human drug products, received a Form FDA 483 citing significant deficiencies across its operations. Key issues include uninvestigated out-of-specification water system results, inadequate laboratory controls for material testing, poorly designed and maintained equipment, and a systemic lack of quality unit oversight. These repeat observations indicate a failure to ensure the quality and purity of drug products.

## Related Documents

- [WARNING_LETTER - 2015-11-30](https://www.globalkeysolutions.net/records/warning_letter/pharmco-laboratories-inc/3aa59e48-cc9c-4f3a-94fa-ce2146b19b61)
- [483 - 2021-09-22](https://www.globalkeysolutions.net/records/483/pharmco-laboratories-inc/8047a27a-811d-40be-8578-1acbe1e7ba66)
- [483 - 2025-03-20](https://www.globalkeysolutions.net/records/483/pharmco-laboratories-inc/307f08c1-f02f-4e7c-a0f8-9ee4b7257176)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9