# FDA 483 - Phoenix Wipes Inc - December 19, 2023

Source: https://www.keypedia.com/records/483/phoenix-wipes-inc/0b58eaa9-6c6f-4fcf-b020-61d1bbe984b5

> FDA 483 for Phoenix Wipes Inc on December 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phoenix Wipes Inc
- Inspection Date: 2023-12-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Phoenix Wipes Inc, an OTC manufacturer in West Babylon, NY, received a Form 483 with nine observations during an inspection from December 4-19, 2023. The observations primarily highlight significant deficiencies in their quality control unit, equipment qualification, process validation, component testing, stability data, annual product reviews, employee training, and record-keeping practices. These issues indicate a lack of established and followed CGMP-compliant procedures for drug product manufacturing and control.

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.keypedia.com/companies/phoenix-wipes-inc/6d8cf93f-b942-469b-a985-2d5b882635eb

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961