When Training Falls Short: FDA Findings on GMP Training Deficiencies in 2025

Adequate training of personnel in the GMP-regulated environment is the basis of a compliant pharmaceutical quality system. Without properly trained staff, product quality, regulatory compliance, and patient safety cannot be ensured. Numerous GMP violations resulting in FDA Warning Letters (and EU Non-GMP Compliance Reports) are caused by a lack of GMP training.

National regulations around the world require sufficient employee training. 21 CFR 211.25, where the requirements for employee training in the US are laid down, explicitly requires that "each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions" (21 CFR 211.25(a)).

Compliance with this regulation is monitored during FDA inspections.

So far in 2025, the FDA has identified a significant number of violations of 21 CFR 211.25 during inspections. The resulting Warning Letters highlight recurring deficiencies in personnel qualification:

• Rite-Kem Incorporated - January 2025
  Finding: "Your quality unit (QU) did not provide adequate oversight… For example, your QU failed to ensure… adequate training for employees engaged in the manufacture, processing, packing, or holding of drug products (21 CFR 211.25(a))."
• Yangzhou Sion Commodity Co., Ltd. - March 2025
  Finding: "Your QU did not provide adequate oversight… For example, your QU failed to… ensure that personnel had adequate training and experience for the production and analysis of (b)(4) drug products (21 CFR 211.25(a))."
• BioAsia Worldwide Sdn Bhd - March 2025
  Finding: "Your quality unit (QU) failed to perform adequate oversight… For example, your QU failed to ensure the following: Establishment of an adequate training program (21 CFR 211.25(a))."
• PMS4PMS, LLC - April 2025
  Finding: "For example, your QU failed to ensure… Operators received adequate CGMP training for the production of OTC drug products (21 CFR 211.25(a))."
• Staska Pharmaceuticals, Inc. - May 2025
  Finding: "Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a))."
• Exela Pharma Sciences, LLC - July 2025
  Finding: "Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a))."

The recently published Warning Letters outline the FDA's expectations for GMP training. All employees involved in the manufacture, processing, packing, or holding of a drug product must be adequately trained and retrained. Training and retraining should be conducted on a regular basis by a qualified trainer. Training must be documented and the success of the training should be assessed.

The findings further indicate that inadequate employee training is a persistent problem and often the root cause of many other violations mentioned in FDA Warning Letters.