# Erode Cancer Centre – FDA 483, Nov 21, 2023

Source: https://www.keypedia.com/records/483/erode-cancer-centre/78ef7752-0480-474a-9d36-03eb0dce0c37

> FDA 483 for Erode Cancer Centre on November 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Erode Cancer Centre
- Inspection Date: 2023-11-21
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Erode Cancer Centre in Erode, India, a biopharmaceutics clinical facility, and issued a Form 483 with two observations. The inspection revealed significant deficiencies in the reporting of adverse events for enrolled subjects and the maintenance of complete case histories. These issues indicate a failure to adhere to good clinical practices during a bioavailability/bioequivalence clinical study.

## Related Officers

- [investigator](https://www.keypedia.com/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.keypedia.com/companies/erode-cancer-centre/8d952bcb-5a81-4637-9f8f-55b3c4c600d6

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c