1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
IntegraDose Compounding Services — FDA 483 Findings
Inspectors Robert J Ham · Kevin P Regan · Melissa M SteigerThe 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, written and followed.
3Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Quality unit oversight
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
6Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
7Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
About this record
Extracted automatically from the document US FDA published on 2024-11-12. 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.
