Drugs

Multiple Violations at U.S. Specialty Formulations

David McFarland

— 2 min read
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A 5/11-5/29/15 FDA inspection at U.S. Specialty Formulations, Bethlehem, PA, found multiple violations and activities that did not meet requirements under Section 503B of the Federal Food, Drug, and Cosmetic Act for drugs produced by an outsourcing facility to qualify for certain exemptions. A 9/30 Warning Letter from the agency’s Philadelphia District Office says the FDA investigators noted that drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health, causing them to be adulterated.

The investigators also found that some of the facility’s drug products did not include required information on the labeling. Also, some of the products did not include information on the container to facilitate adverse event reporting. And the firm failed to submit a report to FDA identifying the drug products that it compounded in the six months before its registration as an outsourcing facility.

Current good manufacturing practice violations cited in the letter included: 

  •          failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
  •          failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
  •          failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
  •          failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
  •          failing to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination;
  •          failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release; and
  •          failing to ensure that each batch of drug product purporting to be sterile and pyrogen-free is laboratory tested to determine conformance to such requirements before release.

The letter also said the company does not have FDA-approved applications on file for its drug products and that its compounded drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and thus adequate directions for their use cannot be written so that a layman can use the products safely for their intended use.

FDA says that some of the firm’s corrective actions appear to be adequate, while others appear to be inadequate. It strongly recommended that the firm’s management undertake a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, materials, and systems, with a particular focus on the aseptic processing operations. It says that a third-party consultant with relevant sterile drug manufacturing experience could be useful in conducting the comprehensive evaluation. “You should fully implement necessary corrections to ensure that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity,” the letter says.

The firm was told to take prompt action to correct the violations and to respond with a list of steps taken and documentation of each step, with a timetable for completion.

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