# Berkshire Sterile Manufacturing, LLC, Lee, MA – FDA Inspections 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. 9 FDA inspections on record (1 OAI), 6 Form 483s, last inspected March 05, 2026. --- ## Details - Name: Berkshire Sterile Manufacturing, LLC - FEI Number: 3012144557 - Business Operations: FDF MANUFACTURE - Address Line 1: 480 Pleasant St - City: Lee - State: Massachusetts - Zip Code: 01238 - Country Name: United States - Address: 480 Pleasant St, Lee, Massachusetts 01238, United States - Country: United States ## 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/72c404f5-4b36-435f-b842-75cb8d607994) — 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 - [483 - Berkshire Sterile Manufacturing, LLC - 2023-01-20](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/e64612df-bfa1-4762-94f8-8710aefa07c0) — source: FDA, date: January 20, 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 - [FDA Inspection 1068306 - Berkshire Sterile Manufacturing, LLC - 2018-10-10](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/32877db4-f664-4f56-9cc1-cf221a25e853) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 10, 2018 - [EIR - Berkshire Sterile Manufacturing, LLC - 2018-04-13](https://www.keypedia.com/records/eir/berkshire-sterile-manufacturing-llc/2f50d62f-bad8-406d-8254-179f29e3e461) — source: FDA, date: April 13, 2018 - [FDA Inspection 1049626 - Berkshire Sterile Manufacturing, LLC - 2018-04-13](https://www.keypedia.com/records/fda_inspections/berkshire-sterile-manufacturing-llc/9372f72c-8871-4b07-ba99-dcf249438c98) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 13, 2018 ## Related Companies - [Par Formulations Private Limited](https://www.keypedia.com/companies/par-formulations-private-limited/5f554b68-cd43-4880-b22b-fca02aab50f0) - [Akeso Biopharma Co., Ltd.](https://www.keypedia.com/companies/akeso-biopharma-co-ltd/5e7be927-b0ec-4dd3-83d6-9a9bd61cf75b) - 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