Home / CFR sections / 21 CFR 211.67(a)

21 CFR 211.67(a) citations

Cleaning / Sanitizing / Maintenance

FDA investigators cited 21 CFR 211.67(a) 948 times at 790 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 3, 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
202657
202585
202457
202350
202240
202126
202034
201976
201870
201744

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 3, 2026USpharma, Ltd., Co.United StatesEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Aug 12, 2026Steril-Gene Life Sciences Private LtdIndiaEquipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 28, 2026Graviti Pharmaceuticals Private LimitedIndiaEquipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 13, 2026Conopco Inc. D/B/A UnileverUnited StatesEquipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 10, 2026Playtex Manufacturing IncUnited StatesEquipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 10, 2026Shine Spect USA, LLCUnited StatesEquipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 9, 2026Lexamed, LtdUnited StatesEquipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 2, 2026Biolink Life Sciences Carolinas Inc.United StatesEquipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 30, 2026Carlsbad Technology, IncUnited StatesEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 26, 2026Advanced Cosmetic Research Laboratories, Inc.United StatesEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 26, 2026AstraZeneca Pharmaceuticals, LPUnited StatesEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 26, 2026Hetero Labs Ltd. Unit VIIndiaEquipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 12, 2026Epic Pharma, LLCUnited StatesEquipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 10, 2026ARx LLCUnited StatesEquipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 5, 2026Access Business Group LLCUnited StatesEquipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 29, 2026Cosmoceutical Research Center, Inc.United StatesEquipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 21, 2026LifeSouth Community Blood Centers, IncUnited StatesEquipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 19, 2026Samchundang Pharm Co., Ltd.Korea (the Republic of)Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 8, 2026Perrigo New York, Inc.United StatesEquipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 8, 2026PPL Healthcare LLCUnited StatesEquipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 5, 2026Digestive Care IncUnited StatesEquipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 4, 2026CTK OTC Laboratories LLCUnited StatesEquipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
May 1, 2026Best Sanitizers IncUnited StatesEquipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Apr 24, 2026Hanlim Pharm Co. Ltd.Korea (the Republic of)Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Apr 21, 2026Ajanta Pharma Ltd.IndiaEquipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

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