Drugs

12 Observations on Imprimis FDA-483

David McFarland

— 2 min read
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FDA has released the FDA-483 issued following a 9/28/20-1/29/21 inspection at the Imprimis NJOF drug compounding outsourcing facility in Lakewood, NJ. The 12 inspection observations, some of which were repeat observations, were: 

  •          failing to thoroughly review any unexplained discrepancy, 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;
  •          failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
  •          failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
  •          failing to submit an adverse event report to FDA following the content and format requirements established through guidance or regulation;
  •          the quality control unit lacks the responsibility and authority to reject all in-process materials and drug products;
  •          failing to have written procedures assigning responsibility, providing cleaning schedules describing in sufficient detail the methods, equipment, and materials to be used for sanitation;
  •          failure of laboratory controls to include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
  •          the facility compounds drug products that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective;
  •          the facility compounds drugs that are essentially a copy of one or more approved drugs;
  •          failing to maintain records so that data therein can be reviewed to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures;
  •          failing to submit a report to FDA identifying the drugs compounded during the previous six-month period; and
  •         compounding drug products using bulk drug substances that cannot be used in compounding under regulations because they (a) are not used to compound drug products that appear on the drug shortage list in effect under law and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

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