1Aseptic processing and sterility assurance
The intended to render final product sterile is nqt adequate to accomplish and/or is not adequate to accomplish <Redacted B4> and/or is not pharmaceutical grade.
Inspection Record
Revive Rx LLC — 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
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 Specifically, A.
3Environmental monitoring
Sinks or drains are present in the cleanroom where the ISO 5 area is located.
4Aseptic processing and sterility assurance
<Redacted B4> glassware used in the processing of sterile drug product is exposed to less than 5 air quality.
5Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
6Aseptic processing and sterility assurance
Cleanroom smoke studies conducted in cleanroom under dynamic oonditions are inadequate.
7Aseptic processing and sterility assurance
There is inadequate HEPA filter coverage or airflow over the area to which sterile product is exposed.
8Equipment and facility
The ISO-classified have difficult to clean, particle-generating, or visibly dirty equipment or surfaces.
About this record
Extracted automatically from the document US FDA published on 2022-09-27. 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.
