1Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
Inspection Record
Spoonamore Drug Co Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release .
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
6Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
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.
