1Aseptic processing and sterility assurance
Equipment and materials or supplies were no disinfected prior to entering the aseptic processing area.
Inspection Record
Front Door Pharmacy, LLC dba Pure Pharmacy — FDA 483 Findings
Inspectors Camerson E MooreThe 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
You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
3Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that prove a challenge to aseptic operations.
4Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
5Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed skin.
6Aseptic processing and sterility assurance
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate.
7Equipment and facility
The ISO-classified areas have difficult to clean, pruticle-generating, or visibly dirty equipment or surfaces.
8Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
