# FDA 483 - Phamedica Inc. - January 10, 2020

Source: https://www.keypedia.com/records/483/phamedica-inc/f4455089-f20f-4f88-9884-d6268c223745

> FDA 483 for Phamedica Inc. on January 10, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Phamedica Inc.
- Inspection Date: 2020-01-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Phamedica Inc., a medical device manufacturer in Plainview, NY, received a Form FDA 483 citing two significant observations. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures, specifically lacking electronic MDR (eMDR) procedures for serious incidents and timely reporting. Additionally, process validation was inadequately documented, with missing serial numbers for materials and calibration records for test equipment.

## Related Documents

- [483 - 2021-12-10](https://www.keypedia.com/records/483/phamedica-inc/dbc20069-ea04-44a9-b84d-fec58d3fe31b)

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/phamedica-inc/48b0ef24-57a6-4166-bd08-46830f1f3d23

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961