# FDA 483 - Novartis Manufacturing LLC - March 04, 2025

Source: https://www.keypedia.com/records/483/novartis-manufacturing-llc/0474f617-f6f5-4b6e-896a-919a765c856e

> FDA 483 for Novartis Manufacturing LLC on March 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Manufacturing LLC
- Inspection Date: 2025-03-04
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Novartis Manufacturing LLC in Indianapolis, IN, a sterile drug manufacturer, identified three significant observations. The firm was cited for failing to adequately qualify component suppliers by verifying their analyses, not including in-process control results in batch production records, and for its quality control unit not consistently following complaint handling procedures, resulting in numerous unresolved complaints. These issues indicate deficiencies in quality control and record-keeping practices.

## Related Documents

- [483 - 2023-10-23](https://www.keypedia.com/records/483/novartis-manufacturing-llc/2c3aed0e-d4f6-4da3-bcf7-f785a222d655)

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

Company: https://www.keypedia.com/companies/novartis-manufacturing-llc/c4165663-ccb2-4abd-bba3-af6a0bdf462d

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03