# FDA 483 - Generitech Corporation - July 28, 2021

Source: https://www.keypedia.com/records/483/generitech-corporation/5df1d5d2-c019-4298-9acb-92fbff36ea55

> FDA 483 for Generitech Corporation on July 28, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Generitech Corporation
- Inspection Date: 2021-07-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Generitech Corporation, an Over the Counter Drug Manufacturer in Fresno, CA, revealed significant deficiencies across multiple systems. The firm failed to thoroughly investigate out-of-specification results, lacked validated test methods and process validation, and exhibited poor control over raw material testing and stability programs. Additionally, issues were noted in batch record completeness, equipment cleaning validation, and overall quality unit responsibilities.

## Related Documents

- [WARNING_LETTER - 2021-07-28](https://www.keypedia.com/records/warning_letter/generitech-corporation/4db40160-0dcd-423c-954d-88f0605d0049)
- [483 - 2023-09-29](https://www.keypedia.com/records/483/generitech-corporation/1c1ef289-bb97-42f1-8d46-4e5759b6d269)

## Related Officers

- [Drug Enforcement Administration](https://www.keypedia.com/people/john-a-gonzalez/51074472-cb23-4b72-8ca7-2d973670063e)

Company: https://www.keypedia.com/companies/generitech-corporation/25805817-388a-4536-8a14-7e1b75078fba

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b