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

Source: https://www.keypedia.com/records/483/bactolac-pharmaceutical-inc/d58b3e6a-6b5d-4d3f-881d-499771520cb9

> FDA 483 for Bactolac Pharmaceutical, Inc. on September 24, 2025. Product: drugs. 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: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Bactolac Pharmaceutical, Inc. in Hauppauge, NY, a dietary supplement manufacturer, received a Form 483 with five observations. The inspection revealed significant issues with product and component specifications, including a lack of established limits for heavy metals and purity, and a failure to follow laboratory procedures for arsenic speciation. Repeated observations highlighted deficiencies in identity testing for dietary ingredients and inadequate scientific rationale for ensuring finished product specifications are met.

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- [483 - 2025-02-07](https://www.keypedia.com/records/483/bactolac-pharmaceutical-inc/478af956-5153-4db0-a53c-4b6fa00c1f95)
- [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)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961