1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
W & C dba The Apothecary — FDA 483 Findings
Inspectors Gregory A Berg · Anthony J Ladner · James K IrelandThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
3Aseptic processing and sterility assurance
OATE(S) OF INSPECTlON 6/6/2016-6/17/201 6* STREIIT ADDRESS 1 65 1 9th St S , Suit e 1 02 TYPE 'ESTABUSHMEHT1NSPECTED Prod u cer of steril e drug product Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to p roduce aseptic conditions.
5Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
6Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
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.
