1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Diamondback Drugs of Delaware, LLC, — FDA 483 Findings
Inspectors Joey V. QuitaniaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Individual equipment logs do not show time, date, product, and lot number of each batch processed.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
4Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
6Documentation and records
Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
7Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
8Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
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.
