FDA 483 - Ameridose, LLC - August 06, 2008

The FDA Form 483 inspection revealed several deficiencies in the firm's manufacturing and quality control processes.

**Key Violations and Observations:**

* **Drug Product Release without Complete Testing:** The firm releases finished drug products (e.g., Fentanyl/Bupivacaine, Sufentanil/Ropivacaine, Oxytocin) for distribution immediately after manufacturing, without performing potency or identity tests on the finished product. Products are shipped before sterility test results are received, despite SOP 9.060 stating products "shall be released on by the quarantine Pharmacist" due to limited Beyond Use dating. * **Inadequate Component Control Procedures:** Written procedures (SOP 5.010) lack sufficient detail for the identification, sampling, and testing of received Active Pharmaceutical Ingredients (APIs). While Certificates of Analysis are received and initial lots validated, not all API lots undergo specific identity testing using USP methods or validated equivalent methods (e.g., Hydromorphone HCL, Ropivacaine). * **Deficient Master Production Records:** Master Production Records (Master Formula Worksheets) do not include theoretical yield statements or minimum/maximum yield percentages (e.g., Fentanyl stock solution, Oxytocin stock solution). * **Incomplete Batch Production Records:** Batch Formula Worksheets for stock solutions and finished products lack documentation of line clearance inspections of packaging and labeling areas before and after use (e.g.,