# FDA 483 - Intergel  Pharmaceuticals, LLC - November 20, 2018

Source: https://www.globalkeysolutions.net/records/483/intergel-pharmaceuticals-llc/98e1ccd4-0d7b-44be-ad24-5da6849f2da9

> FDA 483 for Intergel  Pharmaceuticals, LLC on November 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intergel  Pharmaceuticals, LLC
- Inspection Date: 2018-11-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Intergel Pharmaceuticals, LLC in Irvington, NJ, revealed two significant observations regarding their manufacturing practices. The firm failed to follow written procedures for annual drug product reviews and did not perform routine calibration of mechanical equipment as required. These issues indicate deficiencies in quality control and equipment maintenance that could impact drug product quality.

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/intergel-pharmaceuticals-llc/dea26903-bf97-4337-b7c6-183310a6fb65

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