FDA Warning Letters in 2025 Expose Persistent GMP Training Failures

Adequate employee training is a fundamental requirement of a compliant GMP pharmaceutical quality system. Under 21 CFR 211.25, all personnel involved in manufacturing, processing, packing, or holding drug products must have appropriate education, training, and experience. FDA inspections in 2025 show that this requirement continues to be a major compliance gap.

Multiple firms received Warning Letters citing deficiencies in GMP training and quality unit oversight. These include Rite-Kem Incorporated (January), Yangzhou Sion Commodity Co., Ltd. (March), BioAsia Worldwide Sdn Bhd (March), PMS4PMS, LLC (April), Staska Pharmaceuticals, Inc. (May), Exela Pharma Sciences, LLC (July), and Daewoo Pharmaceutical Co., Ltd. (July). Later in the year, similar findings were issued to PQ Pharmacy, LTC, Wells Pharma of Houston, LLC, DeVere Manufacturing Inc., and Cdymax India Pharma Private Limited.

The FDA emphasized failures such as missing training programs, inadequate operator and inspector qualification, poor documentation, and ineffective retraining. These cases highlight that insufficient GMP training remains a recurring root cause of broader regulatory violations.

09-02-2026