# FDA 483 - Lupin Research Inc - February 19, 2020

Source: https://www.keypedia.com/records/483/lupin-research-inc/de85d291-8556-41e0-8dc7-0a682b52a18c

> FDA 483 for Lupin Research Inc on February 19, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Research Inc
- Inspection Date: 2020-02-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Lupin Research Inc. in Coral Springs, FL, was cited with two observations during an FDA inspection of its inhalation drug product manufacturing. The firm's batch production and control records were found to be incomplete, lacking essential documentation for critical process parameters and product information. Additionally, the quality control unit failed to adequately review the completeness of executed batch production records for validation batches.

## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.keypedia.com/companies/lupin-research-inc/0825eb26-1a4a-4b06-ac92-50c121515bab

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