1Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
Inspection Record
ACRX Specialty Pharmacy lnc — FDA 483 Findings
Inspectors Taichun QinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Your firm produced drug products with materials that had not been verified to assure that they did not contribute to endotoxin contamination that may be objectionable given the product's intended use.
3Contamination control
Non-microbial contamination was observed in your production area.
4Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
About this record
Extracted automatically from the document US FDA published on 2021-10-28. 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.
