# FDA 483 - Poly Pharmaceuticals, Inc - January 24, 2018

Source: https://www.keypedia.com/records/483/poly-pharmaceuticals-inc/c7bd320b-e05c-4d69-8232-8a7a30109bdc

> FDA 483 for Poly Pharmaceuticals, Inc on January 24, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Poly Pharmaceuticals, Inc
- Inspection Date: 2018-01-24
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Poly Pharmaceuticals, Inc. in Owens Cross Roads, AL, an Own Label Drug Distributor, revealed a significant compliance issue regarding adverse drug experience reporting. The firm lacked written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences. Furthermore, the firm's claim of not receiving any adverse drug experience reports for Ibudone tablets over the past six years could not be verified due to the absence of these procedures.

## Related Documents

- [483 - 2018-01-24](https://www.keypedia.com/records/483/poly-pharmaceuticals-inc/838ddf53-8978-49e4-8a6f-5f124d136bee)

## Related Officers

- [investigator](https://www.keypedia.com/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)

Company: https://www.keypedia.com/companies/poly-pharmaceuticals-inc/cd60f9a7-aebf-4d90-a863-901eda452586

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6