# FDA 483 - Goodier Cosmetics LLC - August 23, 2022

Source: https://www.globalkeysolutions.net/records/483/goodier-cosmetics-llc/3c091827-ad82-4215-a1d8-115354d4fbe6

> FDA 483 for Goodier Cosmetics LLC on August 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Goodier Cosmetics LLC
- Inspection Date: 2022-08-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [Acting Program Division Director ](https://www.globalkeysolutions.net/people/charles-d-brown/8b817b44-437e-476c-b2b2-1c4c6e7e7b54)
- [Investigator](https://www.globalkeysolutions.net/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)

Company: https://www.globalkeysolutions.net/companies/goodier-cosmetics-llc/5ea9ed0d-142b-4424-a1d6-be8bb095382d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab
