# FDA 483 - Novartis Manufacturing LLC - October 23, 2023

Source: https://www.keypedia.com/records/483/novartis-manufacturing-llc/2c3aed0e-d4f6-4da3-bcf7-f785a222d655

> FDA 483 for Novartis Manufacturing LLC on October 23, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novartis Manufacturing LLC
- Inspection Date: 2023-10-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Novartis Manufacturing, LLC. in Indianapolis, IN, revealed two significant observations related to the firm's quality control and laboratory operations. The inspection found deficiencies in the completeness of laboratory records for reference standard characterization and inadequate procedures for the acceptance and testing of incoming reference standards. These issues indicate a lack of robust control over critical laboratory materials used in drug product testing.

## Related Documents

- [483 - 2025-03-04](https://www.keypedia.com/records/483/novartis-manufacturing-llc/0474f617-f6f5-4b6e-896a-919a765c856e)

## Related Officers

- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0