1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Inspection Record
Edge Pharma, LLC — FDA 483 Findings
Inspectors John P Mistler · Samir C Gala · Jonah S Ufferfilge and 1 moreThe 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
Test procedures relative to appropriate laboratory testing for sterility are not written and followed.
3Regulatory reporting and change control
Your outsourcing facility has not submitted an adverse event report to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 as required by section503B(b)(5).
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
5Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
6Material and supplier control
Incoming components are not stored under quarantine until they have been tested or examined, as appropriate, and released.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
9Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
11Equipment and facility
Routine calibration and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
12Equipment and facility
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
13Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
About this record
Extracted automatically from the document US FDA published on 2020-10-08. 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.
