483
Safetec Of America, Inc.Safetec Of America, Inc. – FDA 483, Mar 6, 2020
Record Details
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.
View Company Profile
ID · 695b5e0b-b404-44c3-a162-8747745d7e8e
Other documents for Safetec Of America, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.