# FDA 483 - Bactolac Pharmaceutical, Inc. - September 24, 2025

Source: https://www.globalkeysolutions.net/records/483/bactolac-pharmaceutical-inc/857c551c-8f15-45a6-a8be-02e8dae66baa

> FDA 483 for Bactolac Pharmaceutical, Inc. on September 24, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bactolac Pharmaceutical, Inc.
- Inspection Date: 2025-09-24
- Product Type: other
- Office Name: New York District Office
- Summary: Bactolac Pharmaceutical, Inc., a dietary supplement manufacturer in Hauppauge, NY, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish adequate product and component specifications, did not follow its own laboratory procedures, and lacked proper identity testing and scientific rationale for ensuring finished product quality. Several observations were repeats from a previous inspection, indicating persistent issues.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/meredith-p-soehl/52252b59-8f03-41e4-a86f-b92c98048023)

Company: https://www.globalkeysolutions.net/companies/bactolac-pharmaceutical-inc/6448ddc2-938d-490b-960d-d958c552f9bb

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d