Another FDA Warning Letter for inadequate CAPAs
Recommendation
11/12 February 2025
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
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Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent Warning Letter issued by the U.S. Food and Drug Administration (FDA).
In this Warning Letter, the FDA tells an Indian Glenmark site that it failed to investigate "unexplained discrepancy or failure". In particular, FDA found that investigations to identify appropriate root causes were inadequate and that the company failed to implement sustainable corrective action and preventive action (CAPA).
Observations were made in the following systems:
Complaint Handling:
Over the last years, Glenmark received multiple complaints of grittiness for a topical cream. This has been an ongoing formulation issue since 2010 and was a deficiency also cited in previous inspections. The product was reformulated, but the company failed to provide "sufficient data to demonstrate the robustness of the new formulation".
Furthermore, various consumer complaints associated with punctures, cracks, and holes in various container and closure systems were not adequately investigated. Glenmark stated that "the complaint rate is insignificant" and closed most of the complaints, without corrective or preventive actions.
Temperature Excursions
According to the Warning Letter, the company "failed to adequately investigate multiple temperature excursions that occurred during shipping" of drug products. The FDA criticized that investigations performed did not include timely actions to prevent recurrence of the temperature excursions.
Also these deficiencies have been cited during a previous inspection. An adequate risk assessment for products exposed to temperatures outside the labeled storage conditions was not provided. New shipping practices to protect the products "were not implemented in a timely manner".
OOS Handling
After confirmed OOS test results, respective batches were ultimately rejected. However, investigations into these failures "did not determine an appropriate root cause and ensure effective CAPA".
The FDA now expects a "comprehensive, independent assessment" of the system "for investigating deviations, discrepancies, complaints, OOS results, and failures" including a "detailed action plan to remediate this system".
For more details, please see the FDA's Warning Letter to Glenmark Pharmaceuticals Limited.
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