1Documentation and records
Batch production and control records do not include a description of drug product containers and closures used for each batch of drug product produced.
Inspection Record
Total Pharmacy Services, Inc. — FDA 483 Findings
Inspectors Claire M MindenThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
3Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic c onditions.
5Material and supplier control
Reports of analysis from component sup liers are accepted in lieu of testing each component for conformity with all appro priate written specifications, without performing at least one specific identity test on each component and establishing the reliab ility of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
6Aseptic processing and sterility assurance
Procedures designed to prevent m icrobiological contamination of drug products purporting to be sterile do not include validation of the slerilization process.
7Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for the dut ies they perform.
10Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
11Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory detennination of satisfaetory conformance to the identity and strength of each active ingredient prior to release.
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.
