# FDA 483 - Lotte Biologics USA, LLC - June 05, 2019

Source: https://www.globalkeysolutions.net/records/483/lotte-biologics-usa-llc/a3d0045b-bbd4-4a87-b520-06cb96ab02d5

> FDA 483 for Lotte Biologics USA, LLC on June 05, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lotte Biologics USA, LLC
- Inspection Date: 2019-06-05
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Bristol-Myers Squibb Co., Pharmaceutical Research Institute in East Syracuse, NY, from May 28 to June 5, 2019, revealed a significant failure in their quality control processes. The firm did not thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, OOS results were invalidated, and passing retest results were reported without identifying scientifically sound and justifiable root causes.

## Related Documents

- [EIR - 2004-06-16](https://www.globalkeysolutions.net/records/eir/lotte-biologics-usa-llc/99ecde68-c68f-4e18-9855-3f5a8ffdabb2)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/lotte-biologics-usa-llc/97010853-9f18-4cf1-8766-55df585a2452

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248