FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs

FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs

July 1st, 2022 // 1:43 pm @

A drug manufacturing facility that is owned by the Netherlands-based API company Fagron Group is being criticized by FDA after a worker was found destroying a cleaning log. One of the company’s plants in Minnesota got an FDA warning letter in June after a cGMP inspection in 2021 that showed several cross-contamination problems.

FDA stated in its warning letter that the company offered a follow-up cleaning validation record where the firm only checked the carryover of niacin swab samples but did not check progesterone, which was listed in the original cleaning validation.

The letter also noted that the lack of progesterone was a concern because the residue results that failed that were provided to FDA auditors would provide inadequate levels of cross-contamination of progesterone.

The API facility also did not show that it was cleaning the facility as it should, per the FDA warning letter. The letter states that during the API relabeling and repackaging operations, including potent drugs such as estradiol, opioids, and testosterone, the company didn’t do enough cleaning validation studies to show that the firm’s cleaning procedures for its production rooms were enough to prevent cross contamination issues.

The letter also made the serious FDA observation that an employee tore up a cleaning log and the firm could not provide the inspectors a copy. The cleaning log involved one of the cleaning cabins that involved the repackaging of lidocaine HCI.

FDA also found the firm’s response inadequate because it did not demonstrate that its cleaning steps could prevent cross contamination of the repackaged API.

Further, the company did not sufficiently investigate and document OOS results and provide corrective actions. For instance, the warning letter stated that the firm didn’t do an investigation for OOS bioburden counts regarding the water system, which is part of a drug component and no company investigation was done into the improper water test results.

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