# FDA 483 - SUNNY PHARMTECH INC. - November 04, 2022

Source: https://www.keypedia.com/records/483/sunny-pharmtech-inc/c6e16d6c-7323-4534-8de0-fe2ada81b691

> FDA 483 for SUNNY PHARMTECH INC. on November 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUNNY PHARMTECH INC.
- Inspection Date: 2022-11-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of SUNNY PHARMTECH INC in Taoyuan City, Taiwan, a drug and API manufacturer, revealed significant deficiencies in quality control. The firm failed to establish procedures to prevent objectionable microorganisms, maintain and clean equipment adequately, and ensure proper batch production and equipment maintenance records. These issues indicate a lack of robust quality systems, posing potential risks to drug product safety and quality.

## Related Documents

- [483 - 2022-09-29](https://www.keypedia.com/records/483/sunny-pharmtech-inc/21baf5d3-12cc-4929-926a-1986313c7136)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8