1Process validation
Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product.
Inspection Record
Absolute Pharmacy, LLC — FDA 483 Findings
Inspectors Michael H. TollonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation ofthe sterilization process.
4Documentation and records
Batch production and control records do not include complete infonnation relating to the production and control ofeach batch.
5Aseptic processing and sterility assurance
There are no written standards or specifications, methods oftesting, methods of cleaning, methods ofsterilization, and methods ofprocessing to remove pyrogenic properties.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions .
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
8Material and supplier control
Each lot ofa component, drug product containers, and closures liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
9Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
11Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach 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.
