1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
Eagle Pharmacy Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and <Redacted B4> purity.
3Equipment and facility
Equipment ·and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the <Redacted B4> safety; strength, ·quality, .or purity of the drug product.
4Aseptic processing and sterility assurance
Appropriate procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
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.
