Inspection Record

Coast Quality Pharmacy, LLC dba Anazao Health — FDA 483 Findings

US FDAInspected 2019-05-09Published 2019-07-25 5 findingsAseptic processing and sterility assuranceMaterial and supplier controlLaboratory and QC controls

Inspectors Jennifer L HuntingtonThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic 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.

2Aseptic processing and sterility assurance

Disinfecting agents and used in the ISO 5 classified aseptic processing areas were not sterile.

3Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

4Laboratory and QC controls

The written stability program for drug products does not include reliable, meaningful and specific test methods.

5Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.

About this record

Extracted automatically from the document US FDA published on 2019-07-25. 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.

Coast Quality Pharmacy, LLC dba Anazao Health company profile — full history US FDA documents, 2019 Go to Findings search