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FDA warns Florida drugmaker for GMP violations

Posted 12 February 2021 | By Michael Mezher 

FDA warns Florida drugmaker for GMP violations

The US Food and Drug Administration (FDA) last month warned Hialeah, FL-based drugmaker Allay Pharmaceuticals over good manufacturing practice (GMP) issues identified during a rare on-site inspection during the COVID-19 pandemic.
The warning letter cites the company for four issues observed during an inspection in May 2020 involving subpotent products and active pharmaceutical ingredient (API) testing lapses.
FDA says the company “failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.”
“You lacked adequate data to show homogeneity of your drug product during manufacturing,” FDA writes, noting that all three samples it tested during the inspection were subpotent for their active ingredient and one failed for content uniformity.
FDA cites the company for failing to thoroughly investigate a discrepancy after the agency informed it of an out-of-specification (OOS) test result for a lot of one of its products. FDA says the active ingredient assays specifications Allay developed with the company it was contracting for were inappropriate and did not meet the United States Pharmacopeia (USP) monograph specifications for assay acceptance criteria for the product.
“Your investigation into the OOS sample result was inadequate and did not identify [corrective and preventative action] CAPA. Furthermore, an investigation was not performed to ensure that previously released lots met your revised assay specifications. FDA investigators found 13 lots within expiry that exceeded your new assay specification during release or stability testing. These lots should have been identified in your investigation,” FDA writes.
FDA also took issue with Allay’s stability program, finding that the company did not have “adequate long-term stability data to support the commercial size validation batches manufactured using API from a new supplier.” According to FDA, the validation batches using the new API supplier were manufactured in 2019 but not placed into a long-term stability study until almost a year later.
Lastly, FDA cites Allay’s quality unit for failing to adequate oversee the quality of components received from a supplier and the company’s drug manufacturing operations. Here FDA says the quality unit did not adequately evaluate variability in API assay results between tests run by the company and its supplier.
Warning Letter


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