# FDA 483 - SKNV - March 06, 2025

Source: https://www.keypedia.com/records/483/sknv/fab84c86-2e0a-467b-842c-311b2c01faae

> FDA 483 for SKNV on March 06, 2025. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SKNV
- Inspection Date: 2025-03-06
- Office Name: Florida District Office
- Summary: 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)(

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## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/sknv/312c8444-9fc6-4ae1-bff5-8dbdd803988c

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9