Drug factory · FDA FEI 1050589

CMP Pharma, Inc.

8026 East Marlboro Road, Farmville, NC, 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.

Sep 1, 2023 inspection

• 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 batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

Dec 21, 2016 inspection

• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the of post marketing adverse drug experiences.
• Failure to report non-alert ADEs 21 CFR 314.80(c)(2)
  Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report.

May 11, 2016 inspection

• Approval and review of procedures 21 CFR 211.100(a)
  Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
• 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 components and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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.

Oct 24, 2012 inspection

• Identification of containers, lines, equipment 21 CFR 211.105(a)
  All compounding and storage containers and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
• 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.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals in accordance with an established written program.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• Returned drug products with doubt cast as to safety et. al. 21 CFR 211.204
  Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing.
• 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.

Registered with FDA for: analysis; label; manufacture.