Drug factory · FDA FEI 3003734940

Coupler LLC

1140 McDermott Drive, Suite 104, West Chester, PA, 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 2, 2026 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• 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.
• Protection from external factors 21 CFR 211.94(b)
  Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.

Aug 10, 2023 inspection

• Visual inspection 21 CFR 211.122(g)(3)
  The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for examination to be performed by one person and independently verified by a second person.
• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• Theoretical yield statement including percentages 21 CFR 211.186(b)(7)
  Master production and control records lack a statement of theoretical yield.
• 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.
• 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.

Mar 10, 2020 inspection

• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
• 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.
• 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.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Apr 27, 2018 inspection

• Approval and review of procedures 21 CFR 211.100(a)
  Written procedures are not reviewed and approved by the quality control unit.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: repack.