1Validation and qualification
IS0-5 classified areas were not certified under dynamic conditions.
Inspection Record
Prescription Labs Inc dba Greenpark — 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
2Aseptic processing and sterility assurance
No assurance that sterile drug products were processed and stored under ISO 5 quality air.
3Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed skin.
4Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
5Equipment and facility
The facility design was observed to allow the influx.
6Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
7Other quality system
You did not appear to use biological indicators <Redacted B4> during <Redacted B4> and <Redacted B4> of finished drug products.
8Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
9Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
About this record
Extracted automatically from the document US FDA published on 2021-09-17. 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.
