1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug purporting to be sterile do not include adequate validation of the sterilization process.
Inspection Record
AnazaoHealth Corporation — FDA 483 Findings
Inspectors Ashar P. Parikh · Rumany C. PennThe 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
Employees engaged in the processing of a drug product lack the training required to perform their assigned fu nctions.
3Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
6Regulatory reporting and change control
Bulk drug substances used by your outsourcing facility to compound drug products are not each manufacture d by an establishment that is registered under section 510 as required by section 503B(a)(2)(C)
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.
