Home / CFR sections / 21 CFR 211.25(a)

21 CFR 211.25(a) citations

Training--operations, GMPs, written procedures

FDA investigators cited 21 CFR 211.25(a) 1,407 times at 1,137 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 22, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
202624
202562
202450
202334
202234
202142
202032
201983
201893
201796

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Jul 22, 2026Neilmed Pharmaceuticals IncUnited StatesEmployees engaged in the manufacture, processing and packing of a drug product lack the training and experience required to perform their assigned functions.
Jun 26, 2026Biokosmes SrlItalyGMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Jun 26, 2026Boiron Inc.United StatesEmployees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.
Jun 23, 2026Scinopharm Taiwan, Ltd.TaiwanEmployees engaged in the processing of a drug product lack the training required to perform their assigned functions.
Jun 11, 2026Trifluent Pharma LLCUnited StatesGMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Jun 5, 2026My CHS Rx, Inc.United StatesEmployees are not given training in current good manufacturing practices.
Jun 4, 2026Nexus Pharmaceuticals, LLCUnited StatesGMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
May 27, 2026API Solutions Inc.United StatesGMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
May 21, 2026Oakwood Laboratories LLCUnited StatesEmployees engaged in the processing of a drug product lack the training required to perform their assigned functions.
May 14, 2026Appco Pharma LLCUnited StatesEmployees are not given training in the particular operations they perform as part of their function.
Apr 28, 2026Micro Measurement Laboratories, Inc.United StatesGMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
Apr 22, 2026Alcami Carolinas CorporationUnited StatesEmployees engaged in the processing of a drug product lack the training required to perform their assigned functions.
Apr 21, 2026Altaire Pharmaceuticals, Inc.United StatesEmployees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
Apr 3, 2026MD Logistics, LLCUnited StatesEmployees engaged in the packing of a drug product lack the training required to perform their assigned functions.
Apr 2, 2026Baxter Healthcare CorporationUnited StatesEmployees are not given training in the particular operations they perform as part of their function.
Mar 23, 2026Dr. J Skinclinic, IncUnited StatesEmployees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
Feb 27, 2026Gallant Pet IncUnited StatesEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
Feb 12, 2026Tropical Seas, Inc.United StatesEmployees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
Feb 6, 2026Eugia Pharma Specialities LimitedIndiaEmployees are not given training in the particular operations they perform as part of their function.
Jan 22, 2026Creative Werks LLCUnited StatesEmployees engaged in the packing of a drug product lack the education, training and experience required to perform their assigned functions.
Jan 16, 2026Innovatical Laboratories LlcUnited StatesGMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
Dec 19, 2025KaryoLogic IncUnited StatesGMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
Nov 25, 2025Baxter Healthcare CorporationUnited StatesEmployees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Nov 21, 2025Merle Norman Cosmetics, Inc.United StatesGMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Sep 25, 2025PPD Development, L.P.United StatesEmployees engaged in the processing of a drug product lack the training required to perform their assigned functions.

Search more

Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.