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FDCA 501(a)(2)(A) citations

Vermin, production area/adjacent areas

FDA investigators cited FDCA 501(a)(2)(A) 450 times at 115 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Nov 14, 2025. 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
20266
202547
202417
202377
202257
202124
202051
201998
201873

Recent citations

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

Inspection endedFacilityCountryObservation
Nov 14, 2025Empower Clinic Services, LLCUnited StatesFailure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
Nov 14, 2025Empower Clinic Services, LLCUnited StatesPersonnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.
Nov 14, 2025Empower Clinic Services, LLCUnited StatesSmoke studies were inadequately performed under dynamic conditions.
Nov 14, 2025Empower Clinic Services, LLCUnited StatesFailure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
Nov 14, 2025Empower Clinic Services, LLCUnited StatesMicrobial contamination was present in the ISO 5 area.
Nov 14, 2025Empower Clinic Services, LLCUnited StatesPersonnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
Sep 5, 2025North American Custom Laboratories, LLCUnited StatesProduction areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Jul 31, 2025Cardinal Health 414, LLCUnited StatesPersonnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
Jul 31, 2025Cardinal Health 414, LLCUnited StatesLack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
Jun 13, 2025Pharmcore Inc.United StatesMaterials were exposed to lower than ISO 5 quality air.
Jun 13, 2025Pharmcore Inc.United StatesSmoke studies were inadequately performed under dynamic conditions.
Mar 6, 2025SKNVUnited StatesHazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
Feb 28, 2025PALMETTO ISOTOPES, LLCUnited StatesUse of a sporicidal agent in the facility's classified areas was improper.
Feb 28, 2025PALMETTO ISOTOPES, LLCUnited StatesFailure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
Feb 28, 2025PALMETTO ISOTOPES, LLCUnited StatesSmoke studies were not performed under dynamic conditions.
Feb 28, 2025PALMETTO ISOTOPES, LLCUnited StatesPersonnel engaged in aseptic processing were observed wearing non-sterile gloves.
Feb 28, 2025PALMETTO ISOTOPES, LLCUnited StatesProduction areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Feb 28, 2025PALMETTO ISOTOPES, LLCUnited StatesInadequate routine environmental monitoring in the ISO 5 area.
Feb 7, 2025Revive Rx LLCUnited StatesUse of lyophilizers that are not sterilized by routine sterilization cycles and protected from contamination by sterilizing filters on vacuum break air lines/vents.
Feb 7, 2025Revive Rx LLCUnited StatesSmoke studies were not performed under dynamic conditions.
Feb 7, 2025Revive Rx LLCUnited StatesFailure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
Feb 7, 2025Revive Rx LLCUnited StatesFailure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
Feb 7, 2025Revive Rx LLCUnited StatesMicrobial contamination was present in the ISO 5 area and areas adjacent to production areas.
Feb 7, 2025Revive Rx LLCUnited StatesLack of and Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
Feb 7, 2025Revive Rx LLCUnited StatesSterile drugs and Materials were exposed to lower than ISO 5 quality air.

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