# FDA 483 - Bactolac Pharmaceutical, Inc. - June 25, 2015

Source: https://www.globalkeysolutions.net/records/483/bactolac-pharmaceutical-inc/63b4ee4a-6f2a-48ea-b009-1755b80158bf

> FDA 483 for Bactolac Pharmaceutical, Inc. on June 25, 2015. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bactolac Pharmaceutical, Inc.
- Inspection Date: 2015-06-25
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Bactolac Pharmaceutical, Inc., a dietary supplement contract manufacturer in Hauppauge, NY, revealed two significant observations. The firm failed to adequately investigate a product complaint involving metal fragments and did not extend the investigation to other potentially affected batches. Additionally, the company lacked proper quality control review and approval for in-house standard reference materials used in laboratory testing, specifically for botanical identity specifications.

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## Related Officers

- [Eric J. Reisenauer](https://www.globalkeysolutions.net/people/eric-j-reisenauer/28c369cc-bb5c-41f8-a73b-77d85825a10f)

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

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