FDA 483 - Unknown Company - October 23, 1998

The FDA Form 483 details numerous observations regarding a firm's analytical and quality control procedures.

**Key Violations and Observations:**

* **Analytical Run Acceptance Criteria (SOP #F-001):** The SOP is not objective, allowing deletion of calibration standards to meet QC limits and calculating QC accuracy using validated QC values instead of theoretical values, which would otherwise show most QCs failing. Reported assay precision was inaccurate due to exclusion of failed standards and QCs. * **Assay Interference:** No established criteria for determining assay interference, with approximately 30% of pre-dose samples in one study showing significant interference. * **QC Validation (SOP #F-006):** Acceptance criteria for new QCs are not specific, lacking identification of the required number of acceptable new QCs. * **Reference Standards:** * Used as 100% pure despite inadequate purity/potency data on Certificates of Analysis (CoAs). * CoAs for m-hydroxyrimantadine hydrochloride (lot FL-95-31) and p-hydroxyrimantadine hydrochloride (lot JS-111-99) lacked data to show impurity separation by TLC. * CoA for lot 155/103 provided only "satisfactory" TLC results without purity/potency data. * Standards with known lower purities (