Goodier Cosmetics LLCAugust 23, 2022

FDA 483 - Goodier Cosmetics LLC - August 23, 2022

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Goodier Cosmetics LLC, a contract drug manufacturer in Dallas, TX, received a Form 483 citing significant deficiencies in its quality control unit, including failures in reviewing environmental monitoring data, audit trails, and temperature records. Additionally, the inspection revealed inadequate procedures and practices to prevent microbiological contamination during drug product manufacturing, specifically concerning personnel sanitation.

Company: Goodier Cosmetics LLC
Inspection Date: August 23, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
People: Charles D. Brown (Acting Program Division Director )
Shanna N. Purdy (Investigator)

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ID · 3c091827-ad82-4215-a1d8-115354d4fbe6