FDA 483 - Urquima, Sa - September 26, 2016

Urquima, S.A., an API manufacturer, received an FDA Form 483 with two observations during an inspection from September 26-29, 2016. The firm failed to thoroughly investigate out-of-specification results for an API batch, averaging initial OOS results with re-test results without identifying the root cause. Additionally, the company lacked established or followed written procedures for equipment cleaning and maintenance, which led to a drug substance intermediate spillage.