# FDA 483 - Professional Disposables International, Inc. - June 23, 2021

Source: https://www.keypedia.com/records/483/professional-disposables-international-inc/545710da-c3ad-4df9-a232-144d11db60b9

> FDA 483 for Professional Disposables International, Inc. on June 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Professional Disposables International, Inc.
- Inspection Date: 2021-06-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Professional Disposables International, Inc. received an FDA Form 483 citing significant deficiencies across its manufacturing operations. Observations included widespread failures in out-of-specification investigations, inadequate quality control unit procedures, and a failure to submit a required Field Alert Report. The inspection also highlighted issues with laboratory controls, process validation, and equipment design, indicating a systemic lack of adherence to cGMP requirements.

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## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

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