1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Tailor Made Compounding, LLC — FDA 483 Findings
Inspectors Michael P Sheehan · Nicholas L PaulinThe 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
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
3Contamination control
Protective apparel is not worn as necessai·y to protect drug products from contamination.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
5Material and supplier control
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
6Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
7Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other diug products that may have been associated with the specific failure or discrepancy.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
10Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
11Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
About this record
Extracted automatically from the document US FDA published on 2020-02-21. 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.
