1Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
Inspection Record
Delta Pharma Inc. — FDA 483 Findings
Inspectors Zada L. Giles · Marvin D. JonesThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
3Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
4Laboratory and QC controls
Testing and release of drug product for distribution do ·not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
5Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
6Labeling and packaging
The labels of your outsourcing facility's drug products does not include information required bysections 503B(a) (10)(A) and (B).
7Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
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.
