Drug factory · FDA FEI 3009964119

InvaTech Pharma Solutions LLC

40C Cotters Lane, Suite A and 40F Cotters Lane, East Brunswick, NJ, 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.

May 13, 2026 inspection

• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Testing and standardization of standards et. al. 21 CFR 211.194(c)
  Laboratory records do not include complete records of any testing and standardization of laboratory reference standards and standard solutions.
• 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.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components at all times in a manner to prevent contamination.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.

Jun 9, 2023 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.
• 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 SOPs/instructions 21 CFR 211.67(b)(3)
  Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

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