FDA 483 - SKNV - March 06, 2025

From February 13 to March 6, 2025, the FDA inspected SKNV, an outsourcing facility located at 3265 W Mcnab Rd, Pompano Beach, FL. Michael R. Morelli, VP of Scientific Affairs, was issued the Form 483.

The inspection revealed three observations:

1. **Failure to thoroughly review unexplained discrepancies:** * **Magnesium Sulfate for Injection, Lot [(b)(4)]:** On September 18, 2024, the quality unit identified 19 instances of out-of-specification differential pressure readings in the ISO 7 ante-room (ranging from -0.04 to 0.25, specification [(b)(4)] water). Despite attributing this to pre-operation activities and a HEPA motor issue, SKNV lacked an investigation or product impact assessment. This lot was distributed. * **Media Fill (June 13, 2024):** A microbiologic personnel sample yielded *Priestia flexa*. No written investigation was provided regarding origin, cleaning actions, or preventive actions. * **Tretinoin Assay (November 18, 2024):** Product 011009, Lot [(b)(4)], had an out-of-specification Tretinoin Assay result (89.2%, specification [(b)(