FDA 483 - KVK Tech, Inc. - July 08, 2022

KVK-Tech, Inc. received a Form 483 citing significant deficiencies across its manufacturing and quality control operations. Key issues include inadequate facility maintenance leading to repeated water leaks in GMP areas, incomplete cleaning validation for shared equipment, and unsuitable construction of a dispensing room. The firm also failed to thoroughly investigate discrepancies, properly manage consumer complaints, maintain adequate batch records, reconcile rejected materials, and ensure data integrity for laboratory systems.