Drug factory · FDA FEI 3012144557

Sharp Sterile Manufacturing, LLC

480 Pleasant Street, Lee, MA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Mar 5, 2026 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Oct 15, 2021 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
  Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.
• Containers & Closures Clean, Sterilized, Pyrogen-free 21 CFR 211.94(c)
  Drug product containers were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Oct 27, 2020 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not justified.
• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing and processing of the drug product.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• input/output verification 21 CFR 211.68(b)
  Input to and output from records or data are not checked for accuracy. Electronic records are used, but they do not meet systems validation and operational system check requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.