FDA 483 - VP Pharmacy Partners LLC - March 14, 2017

This FDA Form 483 document details observations from an inspection concerning the manufacturing and release of drug products.

**Facility and Operation Details:** The firm produces drug products, including those intended for intrathecal use.

**Violations and Observations:** 1. **Inadequate Product Release Testing:** The testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications prior to release. 2. **Lack of Endotoxin Control:** Products intended for intrathecal use are produced from non-sterile active ingredients that are not controlled for endotoxin levels. Furthermore, the firm does not test the final product to ensure it is within allowable limits for bacterial endotoxins. 3. **Deficient Microbiological Contamination Prevention Procedures:** Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. * **Inadequate Smoke Studies:** Specifically, smoke studies for ISO 5 hood, serial number (b)(4), test report (b)(4), and for ISO 5 hood, serial number (b)(4), test report (b)(4), performed on (b)(4), are inadequate. They failed to demonstrate unidirectional airflow under dynamic conditions to determine how the movement of air and personnel during aseptic operations could pose a risk to products.

**Critical Findings/Deficiencies:** The lack of endotoxin control for intrathecal products and inadequate sterile manufacturing procedures (specifically, smoke studies) are critical