Advanced Cosmetic Research Laboratories, Inc.April 27, 2022

FDA 483 - Advanced Cosmetic Research Laboratories, Inc. - April 27, 2022

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Record Details

Advanced Cosmetic Research Laboratories, Inc. in Chatsworth, CA, received a Form 483 with six observations during an inspection from April 21-27, 2022. The inspection revealed significant deficiencies in quality control unit responsibilities, laboratory testing methods, record-keeping, complaint handling, facility maintenance, and material control. These issues indicate a systemic lack of adherence to good manufacturing practices for OTC drug products.

Company: Advanced Cosmetic Research Laboratories, Inc.
Inspection Date: April 27, 2022
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Sara H. Gabel
Rachel C. Stanton
Rowena S. Nguyen
Roger F. Zabinski (Investigator)

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ID · 3995f1ef-c491-452a-95dd-4209cbb27b5c