# FDA 483 - Health And Natural Beauty USA Corp - October 15, 2024

Source: https://www.keypedia.com/records/483/health-and-natural-beauty-usa-corp/bcd8ab08-6847-4be8-a1ab-4bb920563935

> FDA 483 for Health And Natural Beauty USA Corp on October 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health And Natural Beauty USA Corp
- Inspection Date: 2024-10-15
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Health And Natural Beauty USA Corp, a manufacturer of OTC drug products in Piscataway, NJ, was cited for significant deficiencies during an FDA inspection. The firm lacked adequate stability testing programs, failed to test active ingredients for identity and strength, and maintained deficient batch production records. Additionally, the company failed to perform necessary process validations and equipment qualifications for its OTC drug products.

## Related Documents

- [WARNING_LETTER - 2024-10-15](https://www.keypedia.com/records/warning_letter/health-and-natural-beauty-usa-corp/f579fff6-de44-4958-a985-2de29afa07ce)

## Related Officers

- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/health-and-natural-beauty-usa-corp/a01b34c0-dbcc-40fb-b3f7-e51ea2145a79

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248