# FDA 483 - Medinatura New Mexico, inc. - December 18, 2019

Source: https://www.globalkeysolutions.net/records/483/medinatura-new-mexico-inc/9820eecf-e3d6-4158-b28e-0918e16ffdbc

> FDA 483 for Medinatura New Mexico, inc. on December 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medinatura New Mexico, inc.
- Inspection Date: 2019-12-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Medinatura Inc. in Albuquerque, NM, was inspected by the FDA from December 9-18, 2019. The inspection revealed significant deficiencies in quality control, laboratory operations, and record-keeping practices, indicating a lack of adherence to cGMP regulations. These issues include failures in component rejection, supplier qualification, discrepancy investigations, adherence to specifications, complaint handling, and batch record integrity, posing potential risks to drug product quality and patient safety.

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## Related Officers

- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.globalkeysolutions.net/companies/medinatura-new-mexico-inc/9ac6fb13-d04a-47c0-984a-ed542030da80

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