FDA 483 - Precious Cosmetics Packaging and Consulting Corp. - April 01, 2019

Precious Cosmetics Packaging and Consulting Corp. in Lodi, NJ, a drug manufacturer, received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies across multiple systems, including poor facility maintenance, lack of equipment qualification and cleaning validation, and inadequate batch records. Additionally, the firm lacked a stability program, annual product reviews, sufficient employee training, and proper warehousing procedures, indicating broad non-compliance with current Good Manufacturing Practices for OTC drug products.