Drugs

Multiple Violations at Empower Pharma

David McFarland

— 1 min read
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An 8/1-8/28/2024 FDA inspection at the Empower Pharma drug outsourcing facility in Houston, TX, found that drugs the facility compounds failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA) necessary for the facility to qualify for exemptions from certain provisions of the law. A 4/2 Warning Letter says the agency investigators also noted serious deficiencies in its practices for producing drug products intended or expected to be sterile, which put patients at risk.

The letter lists violations of the FFDCA in terms of adulterated drug products, unapproved new drug products, and misbranded drug products. It also lists these current good manufacturing practice (CGMP) violations:

  • failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
  • failure 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 has already been distributed;
  • failure to establish an adequate system for maintaining equipment used to control the aseptic conditions;
  • failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas; and
  • failure to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

Empower does not have any FDA-approved applications for the products it compounds, the letter says. Its products are misbranded because their labeling fails to have adequate directions for their intended uses.

FDA says some of the firm’s responses to the form FDA-483 that was issued following the inspection appear to be deficient. The agency notes that similar CGMP violations were discussed at a 5/4/2023 regulatory meeting and the company proposed specific remediations at that time. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

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

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