Drugs

Violative Drugs at Avella Specialty Pharmacy

David McFarland

— 1 min read
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A 7/11-7/22/16 FDA inspection at Advanced Pharma, Houston, TX, a drug outsourcing facility now owned by Avella Specialty Pharmacy, found that drugs that violate the Federal Food, Drug, and Cosmetic Act were produced in the facility. An 8/14 Notice of Violation lists these issues: 

  •          failing to meet the conditions of section 503B, meaning that drug products compounded in the facility are not eligible for exemption from FDA approval requirements in section 505, the requirement that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements;
  •          failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
  •          failing to have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory testing to determine satisfactory conformance to final specifications for the drug product;
  •          failing to have approved applications for drug products compounded at the facility; and
  •          failing to have its drug products bear adequate directions for use.

The agency acknowledges company responses to the inspection findings and says that while most corrective actions appear adequate, some of them appear to be deficient. Specifically, it says, there still is concern about the firm’s environmental alert and action limits. FDA also was unable to fully evaluate some of the company’s corrective actions due to a lack of adequate supporting documentation.

Avella was told to respond with a list of specific steps taken to correct the violations with appropriate documentation and a timetable for completion.

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