When Training Fails: FDA Warning Letters Highlight GMP Training Deficiencies in 2026

Adequate training of personnel in the GMP-regulated environment remains the foundation of a compliant pharmaceutical quality system. Without properly trained staff, it is impossible to ensure product quality, regulatory compliance and patient safety. Many GMP violations that result in FDA Warning Letters (and EU Non-GMP Compliance Reports) can be traced back to inadequate GMP training.

Worldwide, national regulations mandate appropriate training of employees. In the US, these requirements are defined in 21 CFR 211.25, which explicitly states 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 assessed during FDA inspections.

To date in 2026, the FDA has identified a substantial number of training deficiencies during inspections. The resulting Warning Letters highlight recurring weaknesses in personnel qualifications:

• GenoGenix LLC - January 2026 - 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))."
• Pro Numb Tattoo Numbing Spray, LLC - April 2026 - Finding: "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))."
• Lexia LLC - April 2026 - Finding: "For example, you failed to ensure the following: (...) Operators received adequate CGMP training for the production of OTC drug products (21 CFR 211.25(a))."

Further findings regarding training deficiencies in FDA Warning Letters include:

• Foshan Miwei Cosmetics Co., Ltd - April 2026 - Finding: "For example, you
  did not review, approve, or implement procedures for critical quality operations such as (...) training management, and handling out-of-specification events."
• GC America, Inc. - May 2026 - Finding: "You also fail to provide updated procedures and training records indicating you have implemented an adequate stability program"
• Shimoga Chemicals - July 2026 - Finding: "Your QU failed to ensure that manufacturing personnel were adequately trained. For example, an analyst who performed unreported injections lacked documented laboratory training and CGMP training. Additionally, no training records were available for a production operator who performed (b)(4) operations on a batch in U.S. distribution."

The 2026 findings once again demonstrate that inadequate employee training is more than just a formal deficiency. It is often the root cause of the many other deviations described in Warning Letters.
Consequently, GMP training programmes that are well designed, well documented, anchored in the quality system and actively supported by management remain essential for sustainable GMP compliance in pharmaceutical companies.