# FDA 483 - Bactolac Pharmaceutical, Inc. - February 07, 2025

Source: https://www.keypedia.com/records/483/bactolac-pharmaceutical-inc/478af956-5153-4db0-a53c-4b6fa00c1f95

> FDA 483 for Bactolac Pharmaceutical, Inc. on February 07, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bactolac Pharmaceutical, Inc.
- Inspection Date: 2025-02-07
- Product Type: other
- Office Name: New York District Office
- Summary: An FDA inspection of Bactolac Pharmaceutical, Inc. in Hauppauge, NY, revealed significant deficiencies in quality control and facility maintenance for dietary supplements. Observations included inadequate testing for finished product specifications and raw material identity, a lack of established contamination limits for components, and improper storage of rejected products. Additionally, the facility exhibited a severe pest infestation and unsanitary conditions, indicating a high risk of product adulteration and contamination.

## Related Documents

- [483 - 2015-06-25](https://www.keypedia.com/records/483/bactolac-pharmaceutical-inc/63b4ee4a-6f2a-48ea-b009-1755b80158bf)
- [483 - 2021-11-19](https://www.keypedia.com/records/483/bactolac-pharmaceutical-inc/e212490d-5689-479c-bddb-1be40103b899)
- [483 - 2025-09-24](https://www.keypedia.com/records/483/bactolac-pharmaceutical-inc/857c551c-8f15-45a6-a8be-02e8dae66baa)

## Related Officers

- [Investigator](https://www.keypedia.com/people/meredith-p-soehl/52252b59-8f03-41e4-a86f-b92c98048023)
- [Investigator -Pathologist](https://www.keypedia.com/people/dana-a-razzano/cc0ae25a-1513-465e-a0df-bb4022e2670c)
- [Joshua D. Lopez](https://www.keypedia.com/people/joshua-d-lopez/d98c14f3-b926-4ebe-94d6-e2260d3b90bd)

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

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