# FDA 483 - Nationwide Laboratories, LLC - November 27, 2018

Source: https://www.keypedia.com/records/483/nationwide-laboratories-llc/029e9a57-884d-41cf-86c4-800d62c25ee5

> FDA 483 for Nationwide Laboratories, LLC on November 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nationwide Laboratories, LLC
- Inspection Date: 2018-11-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Nationwide Laboratories, LLC, an own label distributor, was cited for significant deficiencies in its quality system and postmarketing adverse drug experience procedures. The firm lacks a functional quality control unit, a repeat observation from 2016, and fails to follow written procedures for quality oversight. Additionally, the company has inadequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences to the FDA.

## Related Documents

- [WARNING_LETTER - 2018-11-27](https://www.keypedia.com/records/warning_letter/nationwide-laboratories-llc/96d88411-f9d0-4752-a56e-705f7c831751)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Director of Clinical Training](https://www.keypedia.com/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.keypedia.com/companies/nationwide-laboratories-llc/e5dccf31-f7a6-4a51-9f59-7e2929127933

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248