1Training and personnel
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
Inspection Record
Pine Pharmacy and Home Care Products Center Inc. — FDA 483 Findings
Inspectors Karen L KosarThe 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
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
3Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
4Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Material and supplier control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.
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.
