# FDA 483 - Prodose, Inc. - November 01, 2023

Source: https://www.keypedia.com/records/483/prodose-inc/b74ebc6e-4ac8-48e1-8dbf-e89a13b74163

> FDA 483 for Prodose, Inc. on November 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prodose, Inc.
- Inspection Date: 2023-11-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Spirit Pharmaceuticals, a packager of OTC drug products in Ronkonkoma, NY, revealed significant deficiencies. Observations included inadequate computer system controls with shared passwords, failure to qualify bulk drug product suppliers, and lack of a written stability testing program to support extended expiry dates. These issues indicate a lack of robust quality control and data integrity practices.

## Related Documents

- [WARNING_LETTER - 2025-04-29](https://www.keypedia.com/records/warning_letter/prodose-inc/36e6ee9e-67f7-491a-96ca-d00e3c75b5ec)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)
- [Paige R. McCoy](https://www.keypedia.com/people/paige-r-mccoy/d871e1a3-ec99-4c8b-a12f-477d7719f09a)

Company: https://www.keypedia.com/companies/prodose-inc/10bc1465-5f5a-4e59-a96c-0245116d9fdd

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