Profounda, Inc. – FDA Warning Letter, Aug 9, 2022

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