1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce 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
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Regulatory reporting and change control
Your outsourcing facility has not submitted a report to FDA identifYing a product compounded during the six EMPLOYEE{$) SIGNATURE EMPLOYEE(S} NAME AND TITLE (Print or Type)
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
5Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
7Labeling and packaging
The labels of some of your outsourcing facility's drug products do not include information required by section 503B(a)(IO)(A) and (B).
8Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
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.
