1Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
Inspection Record
Rancho Park Compounding Pharmacy — FDA 483 Findings
Inspectors Taichun QinThe 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
Non-microbial contamination was observed in your production area.
3Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.
4Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
5Aseptic processing and sterility assurance
The segregated production areas sunounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.
6Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
7Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
8Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
9Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement offirst pass air around an open unit, either before or after it was filled with sterile product.
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.
