FDA WARNING_LETTER - Kari Gran Inc. - July 08, 2022

The FDA inspected Kari Gran Inc. (FEI 3015320016) in Seattle, WA, from July 5-8, 2022, and issued a Warning Letter on November 30, 2022, citing significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Product Testing and Stability:** The firm failed to perform adequate release testing for each batch of drug product, specifically for active ingredients like zinc oxide in SPF sunscreens, and did not conduct routine finished product testing or microbiological testing. They also lacked appropriate stability data to support shelf-life claims. 2. **Insufficient Component Testing:** The firm failed to conduct identity testing for each component lot and did not validate supplier test analyses, relying on unverified Certificates of Analysis (COAs). 3. **Deficient Production and Process Controls:** The company lacked adequate validation of manufacturing processes, failing to ensure consistent product quality. Batch production records were incomplete, contained unapproved alterations (white-out, crossed-out data without signatures/dates), and lacked critical manufacturing details. 4. **Quality Control Unit Failures:** The Quality Unit (QU) failed to provide adequate oversight, lacking proper procedures for annual product review, complaint handling, and labeling. A finished product batch was found missing a unique lot number and expiration date.

The FDA deemed the company