# FDA 483 - Profounda Inc - August 30, 2024

Source: https://www.keypedia.com/records/483/profounda-inc/31c91c91-c27b-482e-a56c-96266875c2ce

> FDA 483 for Profounda Inc on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Profounda Inc
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Profounda Inc, an OTC drug manufacturer and own label distributor in Orlando, FL, was inspected and cited for significant deficiencies across its quality system, laboratory controls, and production system. Key issues include a lack of defined quality unit responsibilities, deficient complaint handling procedures, unvalidated microbiology test methods, and unvalidated cleaning processes for equipment. This inspection highlights fundamental gaps in GMP compliance, with one observation being a repeat finding.

## Related Documents

- [483 - 2022-08-09](https://www.keypedia.com/records/483/profounda-inc/0ff2dedc-b837-4760-b471-1ce74815f2db)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)

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