FDA 483 - Miers Laboratories Ltd.

Miers Laboratories Ltd., a drug manufacturer in Wainuiomata, New Zealand, received a Form 483 with six observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to follow written procedures, inadequate component testing, and deficient master production records. Several observations were repeats from a previous inspection, indicating persistent issues with quality system compliance.