# FDA 483 - Phamatech - January 23, 2020

Source: https://www.keypedia.com/records/483/phamatech/a91d8d3c-a325-4559-8de1-1d75ae35f1b6

> FDA 483 for Phamatech on January 23, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phamatech
- Inspection Date: 2020-01-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Phamatech, a medical device manufacturer in San Diego, CA, was inspected by the FDA from January 17-23, 2020. The inspection revealed significant deficiencies in production process monitoring, complaint handling procedures, and the validation of critical manufacturing processes, specifically for HCG test devices. These issues indicate a lack of adequate quality system controls.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/phamatech/d9078410-e0ed-43cd-a96c-a20798dd6bfb

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