FDA 483 - Urquima, Sa - September 26, 2016
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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.
ID · 32d9b78d-2daa-4829-8e81-61b932d5eb11