FDA 483 - Safetec Of America, Inc. - March 06, 2020

Safetec Of America, Inc. in Buffalo, NY was inspected from March 2-6, 2020, revealing significant deficiencies in quality control and equipment maintenance. The firm failed to follow written procedures for non-conformance reports and out-of-specification investigations, and lacked adequate controls over computer systems for master batch records. Additionally, a mixer in a clean room had missing and flaking paint, posing a contamination risk to drug products.