# FDA 483 - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/humanwell-puracap-pharmaceuticals-wuhan-co-ltd/7abf56ab-62b7-4f30-9caf-408534202ff9

> FDA 483 for Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
- Product Type: drugs
- Office Name: Division of Human and Animal Food East V Compliance Branch
- Summary: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd, a pharmaceutical manufacturer, was inspected by the FDA from June 10-14, 2019. The inspection revealed significant deficiencies in maintaining written records for evaluating drug product quality standards and incomplete batch production and control records, indicating a lack of adequate process control and documentation. These issues suggest potential risks to drug product quality and consistency.

## Related Officers

- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.globalkeysolutions.net/companies/humanwell-puracap-pharmaceuticals-wuhan-co-ltd/0e692896-3bde-46a7-95ed-e65be70624d2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-east-v-compliance-branch/00f6013b-7c92-4daf-ae51-d47ab44bf1cb