# FDA 483 - Urquima, Sa - September 26, 2016

Source: https://www.keypedia.com/records/483/urquima-sa/32d9b78d-2daa-4829-8e81-61b932d5eb11

> FDA 483 for Urquima, Sa on September 26, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Urquima, Sa
- Inspection Date: 2016-09-26
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Senior Consultant](https://www.keypedia.com/people/steven-d-kehoe/a080151a-e2eb-436d-95b1-950bde664288)

Company: https://www.keypedia.com/companies/urquima-sa/a9f0bc8c-8119-4927-922c-7c51ceb524e7

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd