# FDA 483 - SUNNY PHARMTECH INC. - September 29, 2022

Source: https://www.keypedia.com/records/483/sunny-pharmtech-inc/21baf5d3-12cc-4929-926a-1986313c7136

> FDA 483 for SUNNY PHARMTECH INC. on September 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUNNY PHARMTECH INC.
- Inspection Date: 2022-09-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: SUNNY PHARMTECH INC, a drug and API manufacturer in Taoyuan City, Taiwan, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination in sterile and non-sterile drug products, failures in quality control unit responsibilities, and a lack of adherence to written production and process control procedures. These issues indicate a systemic breakdown in maintaining a state of control over manufacturing processes and quality systems.

## Related Documents

- [483 - 2022-11-04](https://www.keypedia.com/records/483/sunny-pharmtech-inc/c6e16d6c-7323-4534-8de0-fe2ada81b691)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/sunny-pharmtech-inc/ef1ee573-efce-4b46-a67b-b9dfafc78f82

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