# FDA 483 - PF Consumer Healthcare 1 LLC - April 01, 2019

Source: https://www.keypedia.com/records/483/pf-consumer-healthcare-1-llc/53087236-1bc9-41e4-bcb9-8fd997165ab8

> FDA 483 for PF Consumer Healthcare 1 LLC on April 01, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PF Consumer Healthcare 1 LLC
- Inspection Date: 2019-04-01
- Product Type: device
- Office Name: Atlanta District Office
- Summary: The FDA inspection of PF Consumer Healthcare 1 LLC in Albany, GA, revealed significant deficiencies across its quality system, particularly in complaint handling and corrective actions. The firm failed to adequately investigate complaints, report adverse events in a timely manner, and control nonconforming products, leading to potential risks including burn injuries from their ThermaCare devices. These observations indicate a systemic breakdown in quality management and regulatory compliance, requiring comprehensive remediation.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/lisa-a-warner/3c039e9f-4349-4f3c-bac0-4d12c2cc0660)
- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)
- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/pf-consumer-healthcare-1-llc/16498dee-0f26-4f64-b0d9-af7efe34dcc1

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7