chameleon beverage co. inc. – FDA Warning Letter, Apr 2, 2021

The FDA inspected Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation from March 29 to April 2, 2021, finding hand sanitizer drug products adulterated under 21 U.S.C. 351(a)(2)(A) due to insanitary conditions. Products were manufactured in an unlit, unsealed area exposed to the outside environment, with manual pump filling leaving bulk product open to contamination.

The firm's quality control unit failed to ensure CGMP compliance (21 CFR 211.22), manufacturing hand sanitizer without incoming component identification testing, supplier COA verification, or establishing and performing finished product release testing. The FDA rejected the firm's claim that a customer agreement shifted these responsibilities, asserting the contract manufacturer's obligation to comply with CGMP.

Additionally, the firm failed to establish and follow adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)). No cleaning records or validation studies for the manual pump were provided, and the pump was observed wrapped in plastic tape and rubber gloves. The firm also used a filling line for both hand sanitizer and non-pharmaceutical products (bottled drinking water) without sufficient cleaning procedures or validation studies to prevent cross-contamination.

Furthermore, ALKEMI HAND SANITIZER GEL in 33.8oz containers was misbranded under 21 U.S.C. 3