1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Inspection Record
QuVa Pharma, Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
3Material and supplier control
Jnvestigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
4Equipment and facility
Equipment for adequate control over air pressure, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
5Other quality system
Your compounded drugs that are essentially a copy of one or more approved drugs within the meaning ofsections 503(a)(5) and 503B(d)(2).
6Equipment and facility
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
About this record
Extracted automatically from the document US FDA published on 2019-07-24. 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.
