1Equipment and facility
Inadequate pressure differentials between higher quality air rooms and lower qualit y air rooms were observed.
Inspection Record
Compounded Solutions in Pharmacy, LLC — FDA 483 Findings
Inspectors Mindy M Chou · Johnna L BleemThe 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
Cleaning practices used by the firm for cleaning of ISO 5 areas do not support appropriate environmental cleanliness for sterile drug production.
3Other quality system
The firm held product in conditions that does not ensure the integrity of the finished drug product and could therefore be injurious to health.
4Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
5Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
6Aseptic processing and sterility assurance
The use of sporicidal agents in the clean rooms and ISO 5 classified aseptic processing area was inadequate.
About this record
Extracted automatically from the document US FDA published on 2021-10-07. 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.
