FDA 483 - Boehringer Ingelheim Animal Health do Brasil Ltda. - December 13, 2022

**FDA 483 Summary: Boehringer Ingelheim Animal Health do Brasil Ltda.**

**Inspection Details:** - **Company:** Boehringer Ingelheim Animal Health do Brasil Ltda. - **Location:** Avenida Doutor Roberto Moreira, 5005, Recanto dos Passaros, Paulinia, CEP 13140-970, Brazil - **Inspection Dates:** December 5-13, 2022 - **Type of Establishment:** Animal Drug Manufacturer

**Key Violations/Issues:** 1. **Quality Control Deficiencies:** - The Quality Unit lacked written procedures and failed to address laboratory errors and equipment malfunctions, leading to a 71% invalidation rate of out-of-specification (OOS) test results from January 2020 to November 2022. Personnel issues contributed to 47% of these errors. - Failure to submit a Field Alert to the FDA for OOS assay results during stability testing of Eqvalan (Ivermectin Paste 3%).

2. **Inadequate Investigation and Documentation:** - Failure to thoroughly investigate and document discrepancies and batch failures. Notably, sterility failures in Ivomec Gold Injectable were invalidated without sufficient evidence or comprehensive root cause analysis. - Assay failures for EQVALAN Oral Paste Syringe were invalidated without adequate investigation, attributing errors to sample preparation by inexperienced analysts without clear evidence.

**Regulatory Framework:** The observations highlight non-compliance with FDA regulations regarding quality control and reporting, specifically under the guidance for reporting OOS results and conducting thorough investigations.

**Required Actions:** - Implement comprehensive written procedures for the Quality Unit. - Conduct thorough investigations into OOS results and sterility failures, ensuring all evidence supports the root cause analysis. - Submit required Field Alerts for OOS results as per FDA guidelines. - Enhance training and oversight of personnel to prevent laboratory errors and ensure adherence to procedures.

These actions are crucial to address