# FDA WARNING_LETTER - Profounda, Inc. - August 09, 2022

Source: https://www.keypedia.com/records/warning_letter/profounda-inc/ec2c4c20-c4f7-4fbf-bf09-4e8c999d1b00

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Profounda, Inc.
- Inspection Date: 2022-08-09
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: On February 1, 2023, the FDA issued a Warning Letter to Profounda, Inc. following an inspection from August 3 to August 9, 2022, at their Orlando, FL facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include:
1.  **Failure to establish written procedures for production and process control (21 CFR 211.100(a)):** Profounda lacked validated manufacturing processes for OTC drug products like "Rhinase D," and their response regarding "Rhinase" validation was deemed inadequate due to differing active ingredients.
2.  **Failure to establish an adequate written stability testing program (21 CFR 211.166(a)):** The firm assigned a five-year expiry to "Rhinase D" without sufficient real-time or accelerated stability data, basing it on a different product ("Rhinase").
3.  **Failure to use appropriately designed equipment (21 CFR 211.63):** The purified water system had a dead leg and was not continuously circulating, posing a biofilm risk.
4.  **Inadequate laboratory controls (21 CFR 211.160(b)):** The firm lacked appropriate

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/profounda-inc/7c8159c3-3e7c-4ead-b043-c238c4d50813

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6