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

Source: https://www.keypedia.com/records/483/poly-pharmaceuticals-inc/838ddf53-8978-49e4-8a6f-5f124d136bee

> 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: Florida District Office
- Summary: Poly Pharmaceuticals, Inc., an Own Label Drug Distributor located in Owens Cross Roads, AL, was subject to an FDA inspection from January 22 to January 24, 2018. The inspection resulted in a significant observation documented on Form FDA 483, identifying a critical gap in the company's drug safety monitoring systems. The primary violation observed was the complete absence of written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences to the FDA. The firm asserted they had received no adverse drug experience reports for their Ibudone tablets, which contain hydrocodone bitartrate and ibuprofen, over the previous six years. However, this claim could not be independently verified by the FDA due to the lack of any documented procedures.

This finding indicates a deficiency in adhering to crucial regulatory frameworks concerning pharmacovigilance and drug safety reporting. To address this, Poly Pharmaceuticals, Inc. is required to develop and implement comprehensive written procedures for handling adverse drug experiences. These actions are essential to ensure proper oversight, timely reporting of any future adverse events, and overall compliance with federal regulations designed to protect public health.

## Related Documents

- [483 - 2018-01-24](https://www.keypedia.com/records/483/poly-pharmaceuticals-inc/c7bd320b-e05c-4d69-8232-8a7a30109bdc)

## Related Officers

- [investigator](https://www.keypedia.com/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)
- [President](https://www.keypedia.com/people/chase-c-williams/b38c9f37-ded9-4ecb-97ad-bc658987de21)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9