1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
South Coast Specialty Compounding, Inc. (Park Pharmacy and Compounding) — FDA 483 Findings
Inspectors Caryn M. Mcnab · Jennifer M. GogleyThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation ofthe sterilization process.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
5Stability and storage
The written stahility progrAm for dn1g products does not include test interval s based on statistical criteria for each attribute examined to assure valid estimates ofstability.
6Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
7Stability and storage
Results of stability testing are not used in determining expiration dates.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
