# FDA 483 - AmWiner & Raphe Holdings LLC - August 07, 2024

Source: https://www.globalkeysolutions.net/records/483/amwiner-raphe-holdings-llc/207fb5e9-4a32-4de7-b18b-335131132d2c

> FDA 483 for AmWiner & Raphe Holdings LLC on August 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AmWiner & Raphe Holdings LLC
- Inspection Date: 2024-08-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: AmWiner & Raphe Holdings LLC in Dallas, TX, was inspected and cited for significant deficiencies in its quality control, manufacturing processes, and laboratory operations. The firm failed to conduct essential testing for raw materials and finished drug products, lacked process validation and stability programs, and had issues with equipment maintenance and calibration. These issues indicate a severe lack of adherence to good manufacturing practices for OTC drug products.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)

Company: https://www.globalkeysolutions.net/companies/amwiner-raphe-holdings-llc/d31c7c7b-945f-44a7-9a42-6f47381f7e68

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