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•United States

Berkshire Sterile Manufacturing, LLC, Lee, MA – FDA Inspections

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.

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Company Profile

This profile covers Berkshire Sterile Manufacturing, LLC based in Lee, Massachusetts, United States.

FDA Inspection History

FDA inspections
9
OAI
1
VAI
6
NAI
0
Unclassified
2
Form 483s
6
Warning letters
0

First inspected April 13, 2018. Last inspected March 5, 2026.

Most cited issue areas

  • Procedures for sterile drug products5 inspections
  • Procedures not in writing, fully followed4 inspections
  • Cleaning System3 inspections

FDA inspections (9)

DateResultFDA center(s)Insp. #
March 5, 2026Not classifiedHuman Drugs · Drug Quality Assurance1305732
October 21, 2024Not classifiedHuman Drugs1254740
June 12, 2024VAIBiologics · Human Cellular, Tissue, and Gene Therapies1240940
August 25, 2023VAIHuman Drugs · Drug Quality Assurance1216061
January 20, 2023VAIBiologics · Blood and Blood Products1202788
October 15, 2021VAIHuman Drugs · Drug Quality Assurance1155119
October 27, 2020OAIHuman Drugs · Drug Quality Assurance1132516
October 10, 2018VAIHuman Drugs · Generic Drug Evaluation1068306
April 13, 2018VAIHuman Drugs · Generic Drug Evaluation1049626
FDA documents

Form 483s (8)

  • Form 483s · March 5, 2026
  • Form 483s · October 21, 2024
  • Form 483s · June 12, 2024
  • Form 483s · August 25, 2023
  • Form 483s · January 20, 2023
  • Form 483s · May 23, 2022
  • Form 483s · October 15, 2021
  • Form 483s · October 27, 2020

EIRs (2)

  • EIRs · October 15, 2021
  • EIRs · April 13, 2018
People (5)
Daniel L. Zheng
Person
Mindy M. Chou
Person
Erik W. Koester
Person
Tyler Rush
Person
Steven Kinney
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Par Formulations Private Limited
Akeso Biopharma Co., Ltd.
Grand River Aseptic Manufacturing Inc.
B. Braun US Pharmaceutical Manufacturing LLC
Torbay Pharmaceuticals Ltd.
Thermo Fisher Biopharma Services PTE. LTD
Steriscience Specialties Private Limited
TTY Biopharm Company Limited Lioudu Factory
Jiangsu Hansoh Pharmaceutical Group Co., Ltd
FRESENIUS MEDICAL CARE ANDINA S A S
Company Information

Name

Berkshire Sterile Manufacturing, LLC

FEI Number

3012144557

Address

480 Pleasant St, Lee, Massachusetts 01238, United States

Country

United States

ID: 122082ed-d7d0-478b-8280-8fd8bad790b2

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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