# FDA 483 - PMS4PMS - November 08, 2024

Source: https://www.keypedia.com/records/483/pms4pms/9a695258-6d59-4153-948e-ceabe634a733

> FDA 483 for PMS4PMS on November 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PMS4PMS
- Inspection Date: 2024-11-08
- Product Type: drugs
- Office Name: New York District Office
- Summary: PMS4PMS, an OTC manufacturer in Clarence, NY, was cited for significant deficiencies during an FDA inspection from November 4-8, 2024. The firm lacked a quality control unit and failed to implement essential CGMP-compliant quality systems for its Comforte' Menstrual Cramp Relief Cream. Key issues included inadequate product release testing, raw material testing, unsubstantiated expiration dating, and insufficient employee training.

## Related Documents

- [WARNING_LETTER - 2024-11-08](https://www.keypedia.com/records/warning_letter/pms4pms/ab06c98a-b9b9-495d-98f5-1748d5e1f20a)

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Lauren H. Augustyniak](https://www.keypedia.com/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)
- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/pms4pms/c7713dd4-df45-4fd5-84de-b20d58c91c49

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d