# FDA 483 - Profounda Inc - August 09, 2022

Source: https://www.keypedia.com/records/483/profounda-inc/0ff2dedc-b837-4760-b471-1ce74815f2db

> FDA 483 for Profounda Inc on August 09, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Profounda Inc
- Inspection Date: 2022-08-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Profunda Inc, an OTC drug manufacturer in Orlando, FL, was cited for significant deficiencies across its quality, laboratory, facilities, and production systems during an FDA inspection. Key issues include inadequate complaint handling, lack of investigations for out-of-specification results and missing data, deficient laboratory controls, unsupported expiration dates, and unvalidated manufacturing processes and water systems. These observations indicate a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2024-08-30](https://www.keypedia.com/records/483/profounda-inc/31c91c91-c27b-482e-a56c-96266875c2ce)

## Related Officers

- [Saundra A. Munroe](https://www.keypedia.com/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)
- [issuing_officer](https://www.keypedia.com/people/harshal-j-desai/9ccefb1f-95fc-4a17-9647-eecb5c3ce838)
- [Navista C Bolton](https://www.keypedia.com/people/navista-c-bolton/c86c86ab-86db-4b19-871e-baa3174bdb19)

Company: https://www.keypedia.com/companies/profounda-inc/f0b0632c-a673-4003-926f-00af86a7b53e

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