1Training and personnel
Personnel were observed manually contacting the inner surface of the container or closure.
Inspection Record
First Pharma Associates LLC — FDA 483 Findings
Inspectors Jeffrey P. Raimondi · Linda F. MurphyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
JSO-5 classified areas were not certified under dynamic conditions.
3Equipment and facility
The ISO-classified areas have difficult to clean, particle-generating, or visibly dirty equipment or surfaces.
4Aseptic 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.
5Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product.
6Equipment and facility
The facility is designed and/or operated in a way that permits poor flow of personnel or materials.
7Contamination control
Non-microbial contamination was observed in your production area.
8Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
9Equipment and facility
Inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed.
About this record
Extracted automatically from the document US FDA published on 2019-08-21. 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.
