1Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Inspection Record
Randol Mill Pharmacy — FDA 483 Findings
Inspectors Camerson E MooreThe 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
Your facility design allowed the influx of poor quality air into a higher classified area.
3Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
4Aseptic processing and sterility assurance
Non-sterilized equipment was used in sterile drug production.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purport ing to be sterile are not established and written.
6Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair.
About this record
Extracted automatically from the document US FDA published on 2019-12-18. 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.
