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

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-animal-health-do-brasil-ltda/a3e09544-c39f-4fc0-90da-10151fe21655

> FDA 483 for Boehringer Ingelheim Animal Health do Brasil Ltda. on December 13, 2022. Product: Veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Animal Health do Brasil Ltda.
- Inspection Date: 2022-12-13
- Product Type: Veterinary
- Office Name: Office of Inspections and Investigations
- Summary: **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

## Related Documents

- [483 - 2022-12-13](https://www.keypedia.com/records/483/boehringer-ingelheim-animal-health-do-brasil-ltda/f0d204e8-ee2a-417f-b500-fbe5f84fe1e7)

## Related Officers

- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

Company: https://www.keypedia.com/companies/boehringer-ingelheim-animal-health-do-brasil-ltda/59e04ee8-9fa2-4883-ae50-53e0c748bd80

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8