# FDA 483 - THE HAIN CELESTIAL - October 20, 2023

Source: https://www.keypedia.com/records/483/the-hain-celestial/f252e7bb-4f1c-4e33-b63f-f92c56baf5f1

> FDA 483 for THE HAIN CELESTIAL on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: THE HAIN CELESTIAL
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: THE HAIN CELESTIAL, a drug product manufacturer in Bell, CA, was inspected by the FDA from October 17-20, 2023. The inspection revealed a failure to thoroughly review and investigate out-of-specification viscosity stability for several OTC drug products. Additionally, the firm lacked established control procedures and process validation for various OTC drug products, indicating deficiencies in quality control and manufacturing process oversight.

## Related Officers

- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)
- [Consumer Safety Officer](https://www.keypedia.com/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

Company: https://www.keypedia.com/companies/the-hain-celestial/4e57b7c6-eaf8-47f7-8ca4-3f5c7e652046

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