Quality control is really important for drug manufacturing as far as the FDA is concerned, and when a company isn't even familiar with common QC language it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.
The concerns laid out in the letter, issued to Trans Ox on June 8 and posted by the FDA this week, were significant enough that the FDA recommended that the West Columbia, SC, company hire outside experts to help it get its manufacturing and QA operations in line.
Inspectors were particularly troubled with batch testing after inspectors found "multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing" or from certificates of analysis (CoAs) of its suppliers.
Records said that results from a postfill purity test were obtained by using an oxygen analyzer. But the general manager confessed that was not accurate when the inspector pointed out there were cobwebs between the analyzer and an adjacent wall. He then said they were coming from suppliers' CoAs. But when the CoAs were checked, the inspector found that the records gave purity levels that were higher than the ingredient said they were.
Trans Ox indicated it had updated its processes and manuals but was told it needs to get back to the FDA, not only about the new procedures, but also what it intends to do about retesting product on hand and how it will follow up with clients about product in the market, whether it will recall any and how it will deal with complaints and returns. The FDA was clear about the bottom line for Trans Ox if it doesn't satisfy FDA demands. "Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction."
And the FDA is not shy about sending U.S. Marshals into companies to seize drugs if they think drugmakers are failing to heed its warnings. Last year, marshals seized more than $11 million worth of drugs from a warehouse used by NJ-based Ascend Laboratories, a division of India's Alkem Laboratories, after Ascend ignored FDA warnings that it was selling unapproved drugs. In 2012, the FDA had marshals seize a generic ultrasound transmission gel manufactured by Newark, NJ-based Pharmaceutical Innovations that it said was tainted by bacteria and also seized products from a Maine company that it said was selling unapproved and misbranded drugs.
- read the warning letter