1Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that are not easily cleanable.
Inspection Record
Compounded Solutions in Pharmacy LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
3Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
4Training and personnel
Clothing of personnel engaged in the manufacture of drug products is not appropriate for the duties they perform.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
