# FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/hubei-gedian-humanwell-pharmaceutical-co-ltd/e4fc8729-c2f0-4646-9aab-a0a54de43b45

> FDA 483 for Hubei Gedian Humanwell Pharmaceutical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: This FDA Form 483 was issued to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, China, an API and API intermediate manufacturer, following an inspection from May 9-13, 2016. The inspection revealed two observations related to inadequate calibration of equipment and failure to follow cleaning procedures for sampling rooms. These issues indicate deficiencies in quality control and adherence to standard operating procedures.

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## Related Officers

- [Alice S. Isno](https://www.keypedia.com/people/alice-s-isno/f02e8c83-d02d-42d4-841c-e8cecf7f7909)

Company: https://www.keypedia.com/companies/hubei-gedian-humanwell-pharmaceutical-co-ltd/6e51acbd-3f42-46c6-ad1a-70822bdd7a88

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