Drug factory · FDA FEI 1210513

Sheffield Pharmaceuticals LLC

170 Broad Street, New London, CT, 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.

Jun 18, 2025 inspection

• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the holding of a drug product are not maintained in a good state of repair.
• DHR - UDI not included 21 CFR 820.184(f)
  The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).
• Design history file 21 CFR 820.30(j)
  The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.

Sep 25, 2018 inspection

• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• 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 followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Feb 18, 2016 inspection

• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed .
• Failure to develop written procedures 21 CFR 310.305(a)
  Written procedures have not been developed for the surveillance , receipt , evaluation and reporting to FDA of postmarketing adverse drug experiences.

Mar 19, 2015 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not documented at the time of performance .
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints and recalls and returned or salvaged drug products and investigations conducted for each drug product .
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy .
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function .
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals .
• Identification of actions needed 21 CFR 820.100(a)(3)
  Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.

Registered with FDA for: analysis; label; manufacture.