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

Source: https://www.keypedia.com/records/483/merck-life-science-technologies-nantong-co-ltd/c60898bc-ea02-4476-adfa-14e5848fe394

> 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: Office of Inspections and Investigations
- Summary: An FDA inspection of Merck life Science Technologies (Nantong) Co. Ltd, an excipients and API manufacturer, revealed significant quality control deficiencies. The firm failed to thoroughly investigate customer complaints and deviations, lacked adequate procedures to prevent microbiological contamination of non-sterile products, and had an insufficient stability program. Additionally, the company did not base material sampling amounts on appropriate criteria.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/merck-life-science-technologies-nantong-co-ltd/7a4891fd-9b7e-44c7-86d6-48d40ff4ec8b)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8