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1155119

Sharp Sterile Manufacturing, LLC — FEI 3012144557

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 15, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lee, MA (United States)

Facility

Other inspections at this facility

  • 1240940 (VAI Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216061 (VAI Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202788 (VAI Fri Jan 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1132516 (OAI Tue Oct 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
186921 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
360321 CFR 211.160(b)Scientifically sound laboratory controls
431721 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)