# FDA 483 - Berkshire Sterile Manufacturing, LLC - January 20, 2023

Source: https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/e64612df-bfa1-4762-94f8-8710aefa07c0

> FDA 483 for Berkshire Sterile Manufacturing, LLC on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Center for Biologics Evaluation and Research
- Summary: Berkshire Sterile Manufacturing (BSM) in Lee, MA, an excipient gel manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate written procedures for deviation handling and manufacturing processes, failure to follow raw material management procedures, and lack of established cleaning and validation protocols. These issues indicate a need for improved quality system controls and adherence to cGMP requirements.

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## Related Officers

- [Jie He](https://www.keypedia.com/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)
- [Carl A. Perez](https://www.keypedia.com/people/carl-a-perez/a7214b90-7632-4aff-8afb-33f1d7e7917d)
- [Obinna R. Echeozo](https://www.keypedia.com/people/obinna-r-echeozo/ac368e15-21ee-408f-8b5e-7a9dd0aa3408)
- [Obinna Echozo, Lead Inspector/Microbiologist](https://www.keypedia.com/people/obinna-echozo-lead-inspectormicrobiologist/6211b9c5-1934-419c-a9b3-6573f5cdfbc8)
- [Cynthia Jin, Consumer Safety Officer](https://www.keypedia.com/people/cynthia-jin-consumer-safety-officer/2b26267f-a490-4d73-8adc-445370528b2a)

Company: https://www.keypedia.com/companies/berkshire-sterile-manufacturing-llc/122082ed-d7d0-478b-8280-8fd8bad790b2

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d