1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Inspection Record
American Specialty Pharmacy — FDA 483 Findings
Inspectors Rumany C PennThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment 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.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Other quality system
There are no written procedures for production and process confirms designed to assure that the drug products have the identity, strength, quality, and purity they purport are represented to possess.
5Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
About this record
Extracted automatically from the document US FDA published on 2019-11-14. 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.
