# FDA 483 - Zhangzhou Aoxi Plastics Co., Ltd. - December 04, 2017

Source: https://www.keypedia.com/records/483/zhangzhou-aoxi-plastics-co-ltd/d8358701-b3db-47c9-8c21-8f0bb1390ba1

> FDA 483 for Zhangzhou Aoxi Plastics Co., Ltd. on December 04, 2017. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhangzhou Aoxi Plastics Co., Ltd.
- Inspection Date: 2017-12-04
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Summary: The provided content consists solely of administrative details regarding a Freedom of Information Act (FOIA) request (2018-1113) for FDA records, which were processed and subsequently released on October 28, 2019. It also includes contact information for FDA/CDRH/OCE/DID for status inquiries. The user requested a concise summary, between 150-300 words, of an FDA 483 document. This summary was to specifically include the company name, inspection dates, main violations or issues observed, the applicable regulatory framework, and any required actions. However, the provided text does not contain any substantive information pertaining to an FDA 483 document itself. Crucially, details such as a specific company name, actual inspection dates, descriptions of observed deficiencies or violations, references to a particular regulatory framework, or any mandated corrective actions are entirely absent from the given material. Consequently, it is not possible to generate a summary of an FDA 483 document that includes the requested specific elements, nor to meet the specified word count, as the necessary content for such a summary has not been supplied.

## Related Officers

- [General Manager](https://www.keypedia.com/people/robert-gregory/4a7e46f9-7f3b-43bc-9ed6-8a67777eb0cf)
- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.keypedia.com/companies/zhangzhou-aoxi-plastics-co-ltd/b4d87387-bc2d-4cf7-96fe-5b82c06b1a1a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7