Denison Pharmaceuticals, LLC

Warning LetterOpen

Mr. Jose Gaido President and Chief Executive Officer Denison Pharmaceuticals, LLC 1 Powder Hill Rd. Lincoln , RI 02865 United StatesFEI 1210580Issued Jul 26, 2023Division of Pharmaceutical Quality Operations I

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1210580.

Violations4

Issue DateJul 26, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Denison Pharmaceuticals, LLC
Location: Mr. Jose Gaido President and Chief Executive Officer Denison Pharmaceuticals, LLC 1 Powder Hill Rd. Lincoln , RI 02865 United States
FEI Number: 1210580
Country: United States
Issue Date: July 26, 2023
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Denison Pharmaceuticals was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceutical drugs, including homeopathic products marketed for infants and young children such as "Colic Calm," "Colic Calm +," and "Nauzene Kids." The company failed to thoroughly investigate unexplained discrepancies or batch failures that did not meet specifications, rendering the drug products adulterated and in violation of federal regulations. Additionally, the FDA determined that these homeopathic products were unapproved new drugs being distributed in interstate commerce without proper authorization. The enforcement action was particularly significant given the combination of quality control failures and the vulnerable population—infants and young children—for whom these products were labeled.

Denison Pharmaceuticals, LLC FDA Warning Letter, July 26, 2023