1Computer 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.
Inspection Record
Edge Pharmacy Services, LLC — FDA 483 Findings
Inspectors Niketa Patel · Rachael A MoliverThe 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
6Training and personnel
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the t raining required to perform their assigned functions.
7Quality unit oversight
Adequate lab facilities for testing and approval or rejection of drug products are not available to the quality control unit.
8Labeling and packaging
Strict control is not exercised over labeling issued for use in drug product labeling operations.
9Documentation and records
Procedures for the preparation of master production and control records are not described in a written procedure.
10Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
11Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
12Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of chug products pmpo1ting to be sterile are not established and written.
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.
