1Aseptic processing and sterility assurance
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Inspection Record
Crosby’s Drugs Inc. — FDA 483 Findings
Inspectors Matthew B CasaleThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
3Training and personnel
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate for the duties they perform.
4Aseptic 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.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
7Equipment and facility
The flow of components and in-process materials though the building is not designed to prevent contamination.
8Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
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.
