1Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
Inspection Record
Synthetopes Inc — FDA 483 Findings
Inspectors Jessica L PressleyThe 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 purpoiting to be sterile is not laboratory tested to determine conformance to such requirements.
3Stability and storage
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
4Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent containination that would alter the safety, identity, strength, quality or purity of the drug product.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance the final specifications and identity and strength of each active ingredient prior to release.
About this record
Extracted automatically from the document US FDA published on 2019-10-18. 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.
