# FDA 483 - Professional Disposables International, Inc. - May 28, 2019

Source: https://www.keypedia.com/records/483/professional-disposables-international-inc/2c2f096e-d989-4b27-b9c3-ca5b7e49140a

> FDA 483 for Professional Disposables International, Inc. on May 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Professional Disposables International, Inc.
- Inspection Date: 2019-05-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Professional Disposables International, Inc. in Orangeburg, NY, a drug and device manufacturer, was cited for multiple deficiencies during an FDA inspection. The observations highlight significant issues with data integrity, laboratory controls, quality unit oversight, and validation processes. Key concerns include inadequate computer system controls, uninvestigated out-of-specification results, and failures in managing non-conformances and supplier requirements.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Gregson A Joseph](https://www.keypedia.com/people/gregson-a-joseph/90bf8118-3f32-4f44-95c4-fcde1f741a18)

Company: https://www.keypedia.com/companies/professional-disposables-international-inc/d376f414-c76e-440c-9fbf-f21b65260c53

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961