# CHANGCHUN GENESCIENCE PHARMACEUTICAL CO.,LTD – FDA 483, Apr 24, 2026

Source: https://www.keypedia.com/records/483/changchun-genescience-pharmaceutical-coltd/a42d7116-b1b0-4f7b-84f7-25918a6c8817

> FDA 483 for CHANGCHUN GENESCIENCE PHARMACEUTICAL CO.,LTD on April 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CHANGCHUN GENESCIENCE PHARMACEUTICAL CO.,LTD
- Inspection Date: 2026-04-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Changchun GeneScience Pharmaceutical Co., Ltd. in Changchun, China, revealed significant deficiencies in aseptic processing, quality control, and production procedures for sterile drug products. Observations included inadequate validation of aseptic processes, failure to thoroughly investigate discrepancies like mold contamination and out-of-specification results, and deficiencies in microbiological contamination prevention. The firm also lacked adequate written procedures for visual inspection and failed to establish the accuracy of test methods.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/changchun-genescience-pharmaceutical-coltd/37087747-8cba-4555-babf-24172d0d58ab

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