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# FDA Releases Novartis Untitled Letter on GMPs
- URL: https://www.fdaweb.com/fda-releases-novartis-untitled-letter-on-gmps/
- Published: 2023-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:17:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155925

FDA has just released an 8/8 untitled letter issued following an 11/28-12/9/2022 inspection at the Novartis manufacturing facility in Morris Plains, NJ. The [letter](https://www.fda.gov/media/174213/download?ref=fdaweb.com) says agency investigators documented significant deviations from current good manufacturing practice (CGMP) requirements in the manufacturing of the company’s Kymnah (tisageniecleucel) biologic product. The letter says deviations listed on an FDA-483 were:

- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closure, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
- failing to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they are purported or represented to possess.

The letter told Novartis to respond with a list of specific steps it has taken to correct the noted deviations and prevent their recurrence, with any documentation necessary to show that the issues have been addressed.