FDA 483 - Winder Laboratories, LLC - March 13, 2020

Winder Laboratories, LLC, a drug manufacturer in Winder, GA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies primarily related to the firm's purified water system, including inadequate design, control, maintenance, and monitoring, as well as a failure to test for objectionable microorganisms. Additionally, the firm failed to thoroughly investigate unexplained discrepancies, out-of-specification results, and customer complaints for its elixir and tablet products.