# FDA 483 - Pro-Blending LLC - February 05, 2020

Source: https://www.globalkeysolutions.net/records/483/pro-blending-llc/b531b5cc-6c2d-4477-ab08-57e02647b1f7

> FDA 483 for Pro-Blending LLC on February 05, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pro-Blending LLC
- Inspection Date: 2020-02-05
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Pro-Blending LLC in Linden, NJ, revealed significant deficiencies across its quality system, facilities, laboratory controls, and production processes. The firm lacks a functional quality control unit, proper equipment cleaning procedures, adequate product testing, and stability programs for its drug products, particularly Zinc Oxide 20% Blend. These issues indicate a severe lack of adherence to current Good Manufacturing Practices, posing risks to drug product quality and patient safety.

## Related Officers

- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)

Company: https://www.globalkeysolutions.net/companies/pro-blending-llc/4ff4b060-c9c3-4d16-a1ae-fc2f74dd4054

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248
