Drugs

Profounda ‘Significant’ CGMP Violations

An 8/3-8/9/22 FDA inspection at the Profounda, Inc., drug manufacturing facility in Orlando, FL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/1 Warning Letter says the specific violations were:

failing to establish written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failing to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates;
failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance;
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.

The letter reminds Profounda that it is responsible for the quality of the drugs it produces as a contract facility, regardless of agreements in place with product owners.

FDA says that if Profounda intends to resume manufacturing drugs for the U.S. market, it should engage a qualified consultant to assist it in meeting CGMP requirements.

The firm was told to correct violations promptly and to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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