1Equipment and facility
Inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed.
Inspection Record
Carolina Infusion — FDA 483 Findings
Inspectors Jared P StevensThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Your media fills were not performed under the most challenging or stressful conditions.
3Material and supplier control
Your firm produced drug products with materials that had not been verified to assure that they did not contribute endotoxin contamination that may be objectionable given the product's intended use.
4Material and supplier control
Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.
5Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
About this record
Extracted automatically from the document US FDA published on 2022-11-16. 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.
