NDAL Mfg Inc.

Warning LetterOpen

Mr. Gavin Gear CEO NDAL Mfg Inc. 80 Garden Court, Suite 100 Monterey , CA 93940 United States gavin@ndalmfg.comFEI 3011219618Issued Mar 28, 2022Division of Pharmaceutical Quality Operations IV

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Letter Details

Firm: NDAL Mfg Inc.
Location: Mr. Gavin Gear CEO NDAL Mfg Inc. 80 Garden Court, Suite 100 Monterey , CA 93940 United States gavin@ndalmfg.com
FEI Number: 3011219618
Country: United States
Issue Date: March 28, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

NDAL Mfg Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of finished pharmaceutical products, including nasal spray formulations containing manuka honey, which were also found to be unapproved new drugs. The company's quality control unit failed to exercise proper oversight to ensure drug products met established specifications for identity, strength, quality, and purity, and the firm lacked adequate procedures and a functional quality unit despite utilizing contract manufacturers and retaining responsibility for product release to market. The inspection, conducted from September 8-20, 2021, identified violations under 21 CFR parts 210 and 211, rendering the drug products adulterated and their introduction into interstate commerce prohibited.