Drugs

Violations at Advanced Compounding Solutions

David McFarland

— 2 min read
Share

A 3/21-4/28/22 FDA inspection at New England Life Care, doing business as Advanced Compounding Solutions in Woburn, MA, found multiple violations of the Federal Food, Drug, and Cosmetic Act. A 5/16 Warning Letter says the investigators found serious deficiencies in the company’s practices for producing drug products intended or expected to be sterile, which put patients at risk. The letter says specific violations were:

  • producing adulterated drug products;
  • 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 been distributed;
  • failing to establish and follow adequate written procedures describing the handling of all written and oral complaints about a drug product, including provision for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation;
  • 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 establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
  • failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair; and
  • failing to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure to the aseptic processing area.

The letter also says Advanced does not have FDA-approved applications on file for the drug products that it compounds and is producing misbranded drug products. FDA says it has reviewed the company’s responses to the form FDA-483 issued at the end of the inspection and found that some proposed corrective actions appear to be sufficient, while others cannot be fully evaluated due to a lack of adequate supporting documentation. Further, it says, some of the responses appear to be deficient.

“FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems,” the letter says. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.”

Advanced was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.

Read more