# FDA 483 - KP Pharmaceutical Technology - February 03, 2023

Source: https://www.globalkeysolutions.net/records/483/kp-pharmaceutical-technology/af93ffc6-90c2-4cba-8eba-f8fa21b7a395

> FDA 483 for KP Pharmaceutical Technology on February 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KP Pharmaceutical Technology
- Inspection Date: 2023-02-03
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of KF Pharmaceutical Technology in Bloomington, IN, revealed significant deficiencies in quality assurance procedures and equipment suitability. The firm failed to adequately manage visual inspection processes, environmental controls, and their water system, indicating potential risks to product quality and purity. These issues include lack of AQL testing, unqualified visual inspectors, inadequate particulate control, and insufficient documentation and testing of the water system.

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## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.globalkeysolutions.net/companies/kp-pharmaceutical-technology/acd7d203-2bd2-4702-a902-83c45f57890f

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03