# FDA 483 - GF Health Products, Inc. - November 14, 2019

Source: https://www.globalkeysolutions.net/records/483/gf-health-products-inc/5323a739-146f-4081-8eca-ce6269c3dbe3

> FDA 483 for GF Health Products, Inc. on November 14, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GF Health Products, Inc.
- Inspection Date: 2019-11-14
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: GF Health Products, Inc. in Warwick, RI, a drug manufacturer, was inspected by the FDA, resulting in five observations. The inspection revealed significant deficiencies in laboratory controls, including incomplete record-keeping for calculations and failure to follow established procedures for equipment calibration and document control. Additionally, the firm's batch production records lacked proper personnel identification for critical manufacturing steps, the facility showed poor maintenance with pest entry potential, and access to drug product labels was not adequately controlled.

## Related Documents

- [483 - 2025-06-05](https://www.globalkeysolutions.net/records/483/gf-health-products-inc/9a94e071-3394-46cf-ad67-b1ceb07ba35c)

## Related Officers

- [Program Division Director/District Director](https://www.globalkeysolutions.net/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

Company: https://www.globalkeysolutions.net/companies/gf-health-products-inc/c9d638d3-7b9d-4cd5-b564-a4ab9dc085f6

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94