FDA 483 - Wells Pharmacy, Inc - January 28, 2021

Wells Pharmacy, Inc. in Dyersburg, TN, an outsourcing facility, was cited for numerous serious deficiencies during an FDA inspection. The inspection revealed critical issues including widespread mold contamination in production areas, inadequate quality control oversight, deficient complaint handling, and structural problems in cleanrooms. The firm also failed to report an adverse event in a timely manner and compounded drugs that are essentially copies of approved drugs.