# SUNNY PHARMTECH INC. – FDA 483, Apr 4, 2026

Source: https://www.keypedia.com/records/483/sunny-pharmtech-inc/02a0584a-600d-42c3-8176-a4653146071f

> FDA 483 for SUNNY PHARMTECH INC. on April 04, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUNNY PHARMTECH INC.
- Inspection Date: 2026-04-04
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Sunny Pharmtech Inc. received a severe FDA Form 483 citing widespread deficiencies across its manufacturing and quality control operations, particularly impacting sterile drug products exported to the U.S. market. Key issues include inadequate aseptic process validation, falsification of laboratory data, poor data integrity practices, and a dysfunctional Quality Unit. These failures raise significant concerns about the safety, purity, and quality of the firm's drug products.

## Related Documents

- [483 - 2022-11-04](https://www.keypedia.com/records/483/sunny-pharmtech-inc/c6e16d6c-7323-4534-8de0-fe2ada81b691) — date: November 4, 2022
- [483 - 2022-09-29](https://www.keypedia.com/records/483/sunny-pharmtech-inc/21baf5d3-12cc-4929-926a-1986313c7136) — date: September 29, 2022

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3