Drug factory · FDA FEI 1950222

Meridian Medical Technologies, LLC

1945 Craig Road, St. Louis, MO, 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 30, 2026 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.
• 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 written and followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• Written complaint record to be maintained at facility 21 CFR 211.198(b)
  A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine checking of automatic equipment is not performed according to a written program designed to assure proper performance.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
• Required elements not determined in planning product realization ISO 13485:2016 Clause 7.1
  In product realization planning your firm did not adequately determine, as appropriate, quality objectives and requirements for the product and required activities specific to the product together with criteria for product acceptance.
• Information gathered in feedback process not used as input into risk management ISO 13485:2016 Clause 8.2.1
  Information gathered in the feedback process does not adequately serve as potential input into risk management for monitoring and maintaining product requirements as well as the product realization or improvement processes.

Jun 5, 2024 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.
• 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 written 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 in-process materials and drug products 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 each appropriate specification and 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.
• Lack of or inadequate procedures 21 CFR 820.100(a)
  Procedures for corrective and preventive action have not been adequately established.
• Design output - Lack of or inadequate procedures 21 CFR 820.30(d)
  Procedures for design output have not been adequately established.
• Design validation - Risk analysis 21 CFR 820.30(g)
  Results of the design risk analysis were not adequately documented.
• Purchasing controls, Lack of or inadequate procedures 21 CFR 820.50
  Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.

Dec 21, 2019 inspection

• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful test methods.
• Lack of or inadequate procedures 21 CFR 820.100(a)
  Procedures for corrective and preventive action have not been adequately established.
• Lack of or inadequate complaint procedures 21 CFR 820.198(a)
  Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
• Design verification - output does not meet input requirement 21 CFR 820.30(f)
  Design verification does not confirm that design output meets design input requirements.
• Design validation- Lack of or inadequate procedures 21 CFR 820.30(g)
  Procedures for design validation have not been adequately established.
• Design transfer - Lack of or inadequate procedures 21 CFR 820.30(h)
  Procedures for design transfer have not been adequately established.
• Purchasing controls, Lack of or inadequate procedures 21 CFR 820.50
  Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
• Lack of or inadequate process validation 21 CFR 820.75(a)
  A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• Lack of or inadequate receiving acceptance procedures 21 CFR 820.80(b)
  Procedures for acceptance of incoming product have not been adequately established.
• Lack of or inadequate final acceptance procedures 21 CFR 820.80(d)
  Procedures for finished device acceptance have not been adequately established.
• Nonconforming product, Lack of or inadequate procedures 21 CFR 820.90(a)
  Procedures have not been adequately established to control product that does not conform to specified requirements.

Nov 25, 2014 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
• 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.
• 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.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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 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.
• 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.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
• 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.
• 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 and written procedures required by current good manufacturing practice regulations.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

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