FDA 483 - GRANULATION TECHNOLOGY, INC. - March 02, 2023

This FDA Form 483 was issued to Granulation Technology, Inc. following an inspection that revealed significant deficiencies across multiple quality system areas. The firm failed to thoroughly investigate out-of-specification results and microbial contamination in its water system, lacked adequate change control procedures, and maintained deficient complaint records. Additionally, observations cited inadequate process validation, poor equipment cleaning and maintenance, improper material storage, uncalibrated equipment, and insufficient control over labeling operations.