1Other quality system
I The accuracy, sensitivity, specificity, and reproducibility of tests methods have not been established.
Inspection Record
Downing Labs, LLC — FDA 483 Findings
Inspectors Patrice S. Hall · Jenny Agila Sefen · Jeffrey D. MengThe 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
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
3Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
4Stability and storage
There is no written testing program designed to assess the stability characteris tics of drug products.
5Labeling and packaging
The labels of some of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) and (B).
6Aseptic processing and sterility assurance
Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine conformance to such requirements.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation oftbe sterilization process.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Laboratory 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.
10Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity.
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.
