# FDA 483 - Steri-Pharma, LLC - October 04, 2022

Source: https://www.globalkeysolutions.net/records/483/steri-pharma-llc/bcefd166-90f4-4345-a237-cccc9f40a479

> FDA 483 for Steri-Pharma, LLC on October 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steri-Pharma, LLC
- Inspection Date: 2022-10-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Steri-Pharma, LLC, a sterile drug manufacturer in Syracuse, NY, revealed significant deficiencies in laboratory controls and equipment calibration. The firm failed to follow and document established test procedures for growth promotion and did not adequately calibrate temperature monitoring equipment. These issues indicate a lack of control over critical manufacturing and testing processes.

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- [483 - 2025-08-08](https://www.globalkeysolutions.net/records/483/steri-pharma-llc/cec013e8-5afc-4d97-aca2-5e442b76b08d)

## Related Officers

- [Natasha Gupta](https://www.globalkeysolutions.net/people/natasha-gupta/e91486bd-8b06-411a-b6e6-20e8117a4838)
- [Sam J Zamil](https://www.globalkeysolutions.net/people/sam-j-zamil/8199d01c-86c7-47a3-851b-3c5c40159e8c)
- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.globalkeysolutions.net/companies/steri-pharma-llc/dc07f20b-6149-4c5e-94e0-2a518415a5c1

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