FDA 483 - MYA International, Inc - September 10, 2021

MYA International, Inc. in Chula Vista, CA, received a Form 483 with six observations during an inspection of its dietary supplement manufacturing facility. The firm failed to establish specifications for both components and finished dietary supplements, did not adequately qualify suppliers, and maintained incomplete or missing batch production records. Additionally, processing equipment was not properly identified, leading to unidentified contents in a capsule filling machine.