Failed GMP Training in 2026: Further GMP Training Deficiencies in FDA Warning Letters

Product quality, regulatory compliance, and patient safety all depend on qualified staff. That is why adequate GMP training is the foundation of every pharmaceutical quality system. Inadequate GMP training is also the root cause of many GMP violations that result in FDA Warning Letters and EU GMP Non- Compliance Reports.

The Regulatory Basis: 21 CFR 211.25

In the US, requirements for the appropriate training of employees are defined in 21 CFR 211.25. It 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)).

2026 Findings

In 2026, the FDA continues to identify a substantial number of training deficiencies during inspections. The resulting Warning Letters highlight recurring weaknesses in personnel qualifications and training:

• 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))."
• Suretec Innovations, LLC - August 2026 - Finding: "For example, the QU failed to ensure: (...) An adequate number of qualified personnel to perform and supervise the manufacturing, processing, packing, or holding of each drug product (21 CFR 211.25(c))."
• Pine Pharmaceuticals, LLC - August 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)]."

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."

What are FDA´s Expectations for GMP Training?

The Warning Letters clearly show FDA's expectations for GMP training:

• Regular Training & Retraining: Each employee involved in the manufacture, processing, packing, or holding of a drug product must be properly trained and retrained.
• Qualified Trainer: Training and retraining should be conducted on a regular basis by a qualified trainer.
• Documentation: Training is required to be documented.
• Effectiveness: The success of the training should be assessed.