1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Techni Med, Inc. dba The Compounder — FDA 483 Findings
Inspectors 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
2Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
3Aseptic processing and sterility assurance
Cleaning wipes used in the ISO 5 classified aseptic processing ai·eas were not sterile.
4Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in an area adjacent to the ISO 5 classified aseptic processing area during aseptic production.
5Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
About this record
Extracted automatically from the document US FDA published on 2019-12-18. 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.
