# FDA 483 - Berkshire Sterile Manufacturing, LLC - October 15, 2021

Source: https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/b5f7077b-337b-4218-9a99-5e916009af8c

> FDA 483 for Berkshire Sterile Manufacturing, LLC on October 15, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2021-10-15
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Berkshire Sterile Manufacturing, Inc. in Lee, MA, revealed six observations related to sterile drug product manufacturing. Deficiencies included inadequate sterilization and testing of drug product containers, breaches in aseptic technique, failure to validate supplier test results for components, and significant issues with cleaning and disinfection of aseptic processing areas. Additionally, the firm failed to complete equipment performance qualification and exhibited scientifically unsound laboratory control procedures for product testing.

## 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 - 2024-10-21](https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/1ff36da5-c5f5-408a-ad9b-f8e760d79860)
- [483 - 2024-06-12](https://www.globalkeysolutions.net/records/483/berkshire-sterile-manufacturing-llc/03ad202c-e3c8-476b-8d4f-4aeddef827f2)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7