1Other quality system
Inadequate <Redacted B4> on <Redacted B4> used to sterilize drug products.
Inspection Record
Carolina Infusion LLC — FDA 483 Findings
Inspectors Joanne E KingThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Hazardous drugs and Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning ofwork surfaces, utensils, and/or personnel to prevent cross-contamination.
3Environmental monitoring
The Cleanroom areas contain dust-collecting overhangs without adequate and frequent cleaning.
4Aseptic processing and sterility assurance
There is a lack of HEPA-filtered air and an inadequate HEPA filter coverage or airflow over the critical area to which sterile drug product is exposed.
5Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
6Equipment and facility
Vermin or other animals or evidence of their presence was observed in the areas adjacent to production areas.
7Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
8Equipment and facility
The facility is designed and/or operated in a way that permits poor flow of personnel or materials.
9Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
10Environmental monitoring
Lack of and Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
About this record
Extracted automatically from the document US FDA published on 2026-09-22. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
