# FDA 483 - Medique Products - July 18, 2024

Source: https://www.globalkeysolutions.net/records/483/medique-products/5c337bed-ea73-4608-8e92-04a350144025

> FDA 483 for Medique Products on July 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medique Products
- Inspection Date: 2024-07-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: UniFirst First Aid + Safety in Fort Myers, FL, was inspected from July 16-18, 2024, and received a Form 483. The inspection revealed significant deficiencies in the firm's quality control unit, specifically concerning the inspection and release of incoming finished OTC drug products, the receipt of Certificates of Analysis, and the retention of product samples. These issues indicate a failure to follow established procedures for ensuring product quality and compliance.

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Rodney L. Tinzie](https://www.globalkeysolutions.net/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)

Company: https://www.globalkeysolutions.net/companies/medique-products/756b0443-3dee-4c5d-91b1-f691bf99f70b

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