# FDA 483 - Merck Life Science Technologies (Nantong) Co., Ltd. - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/merck-life-science-technologies-nantong-co-ltd/7a4891fd-9b7e-44c7-86d6-48d40ff4ec8b

> FDA 483 for Merck Life Science Technologies (Nantong) Co., Ltd. on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck Life Science Technologies (Nantong) Co., Ltd.
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Merck Life Science Technologies (Nantong) Co. Ltd, an excipients and API manufacturer in Nantong, China, revealed significant quality control deficiencies. Observations included inadequate investigations into customer complaints and deviations, a lack of procedures to prevent microbiological contamination of non-sterile products, and failures in the stability testing program and material sampling criteria.

## Related Documents

- [483 - 2025-03-14](https://www.globalkeysolutions.net/records/483/merck-life-science-technologies-nantong-co-ltd/c60898bc-ea02-4476-adfa-14e5848fe394)

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/merck-life-science-technologies-nantong-co-ltd/37493d9d-656d-4dc2-ab62-650cd0281a8d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd