Drug factory · FDA FEI 3003693105

Corium Innovations, Inc.

4558 50th Street SE, Grand Rapids, MI, 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.

Nov 18, 2022 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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 not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Written procedures lacking for use of pesticides etc. 21 CFR 211.56(c)
  Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of components, drug product containers, closures and packaging, labeling materials.

Dec 21, 2012 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
• Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
  Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.

Nov 7, 2011 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not followed that describe the tests to be conducted on appropriate samples of in-process materials of each batch.
• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not derived from previous acceptable process average and process variability estimates where possible.
• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
• 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 drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
• 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 and fully followed.
• 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.
• Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
  Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Oct 29, 2010 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.

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