# FDA 483 - Puremedy Inc. - July 26, 2024

Source: https://www.keypedia.com/records/483/puremedy-inc/f8f19298-11f1-4945-bf2e-8c7bc39a4097

> FDA 483 for Puremedy Inc. on July 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Puremedy Inc.
- Inspection Date: 2024-07-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Puremedy Inc., a manufacturer of homeopathic drug products, revealed significant deficiencies across its production, quality, and laboratory systems. The firm failed to establish written procedures for process controls, quality control unit responsibilities, and lacked essential testing for finished products and raw materials. Several critical observations, including lack of process validation, stability data, and equipment calibration, were repeat findings, highlighting persistent non-compliance with manufacturing regulations.

## Related Documents

- [483 - 2024-02-12](https://www.keypedia.com/records/483/puremedy-inc/2275324a-1216-4bc1-918a-9db30b6affd1)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.keypedia.com/companies/puremedy-inc/89f36894-f42e-4af8-981c-d06ccb5c6514

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