# FDA 483 - Tropichem Research Labs, LLC dba Vetio - December 14, 2018

Source: https://www.globalkeysolutions.net/records/483/tropichem-research-labs-llc-dba-vetio/b6a2d1db-20b3-432a-a180-75385ceaf7c6

> FDA 483 for Tropichem Research Labs, LLC dba Vetio on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tropichem Research Labs, LLC dba Vetio
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: ProfiChem Research Labs, LLC dba Vetio Animal Health in Jupiter, FL, a drug manufacturer, received a Form 483 with seven observations during an inspection from December 10-14, 2018. The inspection revealed significant deficiencies in quality control, including failures to investigate out-of-specification results, inadequate finished product testing, poor computer system controls, and lack of equipment qualification, process validation, and stability data for animal drug products. Several observations were repeats from a previous inspection, indicating persistent issues.

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## Related Officers

- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.globalkeysolutions.net/companies/tropichem-research-labs-llc-dba-vetio/d5309ec0-6e22-4393-b075-4b8c7d432276

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6