1Stability and storage
There is no written testing program designed to assess t e stability characteristics of drug products.
Inspection Record
Cape Apothecary Inc. — FDA 483 Findings
Inspectors Nebil At Owner · Qin XuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Procedures designed to prevent m icrobiological contamination of drug products purporting to be sterile are not established.
5Equipment and facility
J Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
6Aseptic processing and sterility assurance
Producer of Sterile and non-sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
7Aseptic processing and sterility assurance
STReET AOORESS 1384 Cape Saint Cl aire Rd TYPE ESTABUSHMEHT INSP£CTEO Producer of Ste r i l e and non- s teril e d rug products Each batch of drug product purporting to be sterile is no t laboratory tested to determine conformance to such requirements.
8Aseptic processing and sterility assurance
A septic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
10Deviation, CAPA, and investigation
There is a failure to thoroughly re view any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch been already distributed.
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.
