# FDA 483 - Gadal Laboratories Inc. - February 17, 2023

Source: https://www.keypedia.com/records/483/gadal-laboratories-inc/371ef02c-7263-4114-9001-7466ff6ddc70

> FDA 483 for Gadal Laboratories Inc. on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Gadal Laboratories Inc.
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Gadal Laboratories Inc, an OTC drug manufacturer in Miami, Florida, was inspected by the FDA from February 13-17, 2023. The inspection revealed numerous significant deficiencies across its production, laboratory, facilities and equipment, materials, quality, and packaging and labeling systems. Key issues included inadequate quality unit oversight, poor data integrity practices, insufficient equipment qualification, and a lack of robust investigation and change control procedures, indicating a systemic failure to adhere to Good Manufacturing Practices.

## Related Documents

- [483 - 2016-04-28](https://www.keypedia.com/records/483/gadal-laboratories-inc/d3d5f494-7bcf-47a9-b56f-e89798e49607)
- [WARNING_LETTER - 2023-02-17](https://www.keypedia.com/records/warning_letter/gadal-laboratories-inc/dffe4961-5a48-41fe-a8a4-f75512d798cd)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/gadal-laboratories-inc/ab020b2d-bc0c-4731-bc27-f75fc34163d4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6