483
Intergel Pharmaceuticals, LLCIntergel Pharmaceuticals, LLC – FDA 483, Nov 20, 2018
Record Details
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.
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ID · 98e1ccd4-0d7b-44be-ad24-5da6849f2da9
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