# FDA 483 - Ningbo Pulisi Daily Chemical Products Co., Ltd - February 28, 2019

Source: https://www.globalkeysolutions.net/records/483/ningbo-pulisi-daily-chemical-products-co-ltd/8377e67a-baa8-4114-8e13-46eca8d2d3a7

> FDA 483 for Ningbo Pulisi Daily Chemical Products Co., Ltd on February 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ningbo Pulisi Daily Chemical Products Co., Ltd
- Inspection Date: 2019-02-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Ningbo Pulisi Daily Chemical Products Co., Ltd, an OTC drug manufacturer, revealed 18 significant deficiencies in their manufacturing operations. The observations highlight a widespread lack of adherence to Good Manufacturing Practices, including inadequate product testing, poor facility and equipment maintenance, insufficient process validation, and deficient record-keeping and quality control procedures. These issues raise concerns about the identity, strength, quality, and purity of their OTC drug products.

## Related Documents

- [WARNING_LETTER - 2019-02-28](https://www.globalkeysolutions.net/records/warning_letter/ningbo-pulisi-daily-chemical-products-co-ltd/68374d6d-c7d8-449d-ae98-58f80c117d86)

## Related Officers

- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/ningbo-pulisi-daily-chemical-products-co-ltd/067ebaaf-cf2b-4215-b3ea-8f54b5fdf582

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1