FDA 483 - PharmaKon Pharmaceuticals - April 08, 2014

The FDA Form 483 documents observations from an inspection, indicating a failure to follow written production and process control procedures.

**Key Observations:**

* **Recall Procedures Not Followed:** Recall Procedures SOP PL 122 states QA is responsible for issuing recalls. However, Incident Report 001, dated March 26, 2014, noted mislabeling of NDC 45183-001-05 (Midazolam) with an incorrect concentration (0.1mg/mL instead of 0.2mg/mL), but no recall was issued. The labels for Midazolam lots E0433735C and E1016227C incorrectly stated "Midazolam 0.2mg/2mL 0.9% Sodium Chloride Total dosage: 0.4 mg per 2mL." * **Labeling System Deficiencies:** Labeling: Printing and Issuance SOP PH127 requires label templates to be on a specific system accessible only by authorized personnel, with labels printed and verified by a manager or QA. The system used for storing templates and printing labels lacks an audit trail, security access, user role permissions, or user controls to ensure only authorized personnel can access template files. * **Unauthorized Label Template Change and Lack of Verification:** The label template for Midazolam 0.2mg/2mL in