# FDA 483 - Weckerle Cosmetics USA, INC - March 26, 2021

Source: https://www.globalkeysolutions.net/records/483/weckerle-cosmetics-usa-inc/aec7231d-d29f-44f0-a09b-b5a531499b48

> FDA 483 for Weckerle Cosmetics USA, INC on March 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Weckerle Cosmetics USA, INC
- Inspection Date: 2021-03-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Weckerle Cosmetics USA, INC in Torrance, CA, was inspected and received nine observations related to significant deficiencies in their quality control, record-keeping, equipment maintenance, and laboratory systems. Key issues include a lack of investigations into failed tests, inadequate annual product reviews, insufficient supplier qualification, and poor data integrity controls for analytical equipment. These findings indicate a broad failure to adhere to good manufacturing practices for drug products.

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- [483 - 2025-10-31](https://www.globalkeysolutions.net/records/483/weckerle-cosmetics-usa-inc/9649fed1-b63d-41c8-8755-dbe5328d455e)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/weckerle-cosmetics-usa-inc/7cc2d9ab-5729-4941-bd1b-2681b7fdf78f

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6