# Berkshire Sterile Manufacturing, LLC - Inspection Records

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

> Inspection records and compliance data for Berkshire Sterile Manufacturing, LLC in Lee, Massachusetts. Access full analysis and detailed observations.

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## Details

- Name: Berkshire Sterile Manufacturing, LLC
- FEI Number: 3012144557
- City: Lee
- State: Massachusetts
- Country Name: United States
- Address Line 1: 480 Pleasant St
- Zip Code: 01238
- Business Operations: FDF MANUFACTURE

## Related Documents

- [483 - Berkshire Sterile Manufacturing, LLC - 2026-03-05](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/ff12db27-ddb1-4962-8899-635e77cc23e0) — source: FDA, date: March 5, 2026
- [FDA Inspection 1305732 - Berkshire Sterile Manufacturing, LLC - 2026-03-05](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/51854cab-8d3e-41dd-8216-3fae5bc072e3) — source: FDA, date: March 5, 2026
- [483 - Berkshire Sterile Manufacturing, LLC - 2024-10-21](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/1ff36da5-c5f5-408a-ad9b-f8e760d79860) — source: FDA, date: October 21, 2024
- [FDA Inspection 1254740 - Berkshire Sterile Manufacturing, LLC - 2024-10-21](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/ddad3945-cd4d-4804-b899-0274a5a38c4c) — source: FDA, date: October 21, 2024
- [483 - Berkshire Sterile Manufacturing, LLC - 2024-06-12](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/03ad202c-e3c8-476b-8d4f-4aeddef827f2) — source: FDA, date: June 12, 2024
- [FDA Inspection 1240940 - Berkshire Sterile Manufacturing, LLC - 2024-06-12](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/9be0692d-4278-4a48-acf6-6a063244f8c2) — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 12, 2024
- [483 - Berkshire Sterile Manufacturing, LLC - 2023-08-25](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/dfe773a7-405c-4d31-aaf3-9e6ff342adc9) — source: FDA, date: August 25, 2023
- [FDA Inspection 1216061 - Berkshire Sterile Manufacturing, LLC - 2023-08-25](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/fc1f3ae4-1437-434d-ae81-c02182a4a89a) — classification: Voluntary Action Indicated (VAI), source: FDA, date: August 25, 2023
- [FDA Inspection 1202788 - Berkshire Sterile Manufacturing, LLC - 2023-01-20](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/186db2dd-a002-4077-87fc-27f0b21dbc8f) — classification: Voluntary Action Indicated (VAI), source: FDA, date: January 20, 2023
- [483 - Berkshire Sterile Manufacturing, LLC - 2022-05-23](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/0242d85d-cd8d-446f-8097-deda3e11a05e) — source: FDA, date: May 23, 2022
- [483 - Berkshire Sterile Manufacturing, LLC - 2021-10-15](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/b5f7077b-337b-4218-9a99-5e916009af8c) — source: FDA, date: October 15, 2021
- [EIR - Berkshire Sterile Manufacturing, LLC - 2021-10-15](https://www.keypedia.com/records/eir/berkshire-sterile-manufacturing-llc/012a27c7-8b9d-4727-b75a-0e5804cad8d1) — source: FDA, date: October 15, 2021
- [FDA Inspection 1155119 - Berkshire Sterile Manufacturing, LLC - 2021-10-15](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/871b45a1-0d7e-4f23-a7be-66f5b69fc0c0) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 15, 2021
- [483 - Berkshire Sterile Manufacturing, LLC - 2020-10-27](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/41216297-9af0-4848-860e-e6b26912edd0) — source: FDA, date: October 27, 2020
- [FDA Inspection 1132516 - Berkshire Sterile Manufacturing, LLC - 2020-10-27](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/96922145-9de3-4fd8-b1ee-16cbc06d6810) — classification: Official Action Indicated (OAI), source: FDA, date: October 27, 2020

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## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [company_representative](https://www.keypedia.com/people/tyler-rush/00205e85-e88c-4081-997e-59dd99cbcec7)
- [company_representative](https://www.keypedia.com/people/steven-kinney/0f196221-ebd7-4210-a337-f6d2cf44567e)
- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)