# 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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- [WARNING_LETTER - 2021-06-23](https://www.keypedia.com/records/warning_letter/professional-disposables-international-inc/8825c59a-02af-4b98-9e13-1e8ac8669bdf)
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## Related Officers

- [Vivin George, Investigator](https://www.keypedia.com/people/vivin-george-investigator/75670ca1-ec63-4dbd-a763-2c4aa31bac6a)
- [Lata C. Mathew, Ph.D., Investigator](https://www.keypedia.com/people/lata-c-mathew-phd-investigator/f0682266-2ed3-4fd5-b64d-62944651792c)

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