Dynalabs LLC – FDA 483, Oct 29, 2012

The FDA Form 483 details significant deficiencies in a facility's quality control and manufacturing processes.

**Sterility Testing and Procedures:** * The firm issues Certificates of Analysis (CoAs) citing USP <71> for sterility testing but does not follow its requirements for the number of articles to be tested based on batch size. * Batch size information is not required from clients, nor is there documentation to ensure clients submit the correct number of articles for initial or re-testing. * Specifically, for drug product glutathione/vitamin C/DMOS, lot (b)(4), the required number of articles per USP <71> was not submitted for testing or re-testing. * Procedure MIC-SOP-0016 for re-testing is inadequate, lacking definitions for "proven lab error" and documentation requirements for invalidation and re-testing of initial out-of-specification (OOS) results.

**Laboratory Controls and Potency Analysis:** * No written procedure exists for potency analysis of methylprednisolone. * Sample calculations for potency analysis lack descriptions in analytical worksheets or written procedures, including drug product bug volume corrections. This was observed in multiple investigation reports for various drug products. * Sample preparation descriptions in test schedules are insufficient, lacking details on sample handling, equipment type (e.g., autopipette), glassware, and protection from degradation (e.g., for methylpred