# FDA 483 - Berkshire Sterile Manufacturing, LLC - October 21, 2024

Source: https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/1ff36da5-c5f5-408a-ad9b-f8e760d79860

> FDA 483 for Berkshire Sterile Manufacturing, LLC on October 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2024-10-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Berkshire Sterile Manufacturing in Lee, MA, was inspected from October 14-21, 2024, and received eight observations primarily related to significant deficiencies in aseptic processing, environmental monitoring, and quality control. The findings indicate a high risk of microbial contamination and product quality issues due to inadequate procedures, training, and facility maintenance.

## Related Documents

- [EIR - 2021-10-15](https://www.globalkeysolutions.net/records/eir/berkshire-sterile-manufacturing-llc/012a27c7-8b9d-4727-b75a-0e5804cad8d1)
- [483 - 2020-10-27](https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/41216297-9af0-4848-860e-e6b26912edd0)
- [483 - 2026-03-05](https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/ff12db27-ddb1-4962-8899-635e77cc23e0)
- [483 - 2024-06-12](https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/03ad202c-e3c8-476b-8d4f-4aeddef827f2)
- [483 - 2022-05-23](https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/0242d85d-cd8d-446f-8097-deda3e11a05e)

## Related Officers

- [Hamed Touré](https://www.globalkeysolutions.net/people/hamed-toure/ad275adf-1894-4bf0-9a54-9e4588c387ed)
- [Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd