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# CGMP Issues in Nantong Furuida Records Review
- URL: https://www.fdaweb.com/cgmp-issues-in-nantong-furuida-records-review/
- Published: 2024-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:22:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156298

FDA says its review of records requested from Nantong Furuida Packaging Products Co., Ltd., in Jiangsu Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drugs. A just-released 11/17/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nantong-furuida-packaging-products-co-ltd-667984-11172023?ref=fdaweb.com) says the specific violation was failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

The letter says the company was asked for information on its stability program and provided accelerated study reports for three of its products. “You failed to provide evidence of long-term stability studies to corroborate product stability projections from the accelerated studies,” FDA says. “In addition, you failed to provide any stability program demonstration. You have not provided adequate evidence to support the expiry dates on your products.”

The agency recommends that Nantong engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. FDA placed Nantong on an import alert on 10/26/23.

The firm was told to correct violations promptly and to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.