# FDA 483 - Unit Dose Services, LLC - January 31, 2020

Source: https://www.globalkeysolutions.net/records/483/unit-dose-services-llc/63fe7b15-fa64-4315-80f0-6c7bd48c3fce

> FDA 483 for Unit Dose Services, LLC on January 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unit Dose Services, LLC
- Inspection Date: 2020-01-31
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Unit Dose Services, LLC in Dania, FL, revealed significant deficiencies in its quality control unit and cGMP systems. The firm lacked a Quality Manager, failed to investigate out-of-specification data, and did not perform essential quality functions. Additionally, investigation records for discrepancies were incomplete, and critical equipment used in repacking/filling operations lacked qualification, preventative maintenance, and cleaning validation.

## Related Documents

- [WARNING_LETTER - 2022-10-25](https://www.globalkeysolutions.net/records/warning_letter/unit-dose-services-llc/71a3fe1b-f675-4f9a-9b52-f3354364e369)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/unit-dose-services-llc/6a9753dd-3109-4925-bc08-290f063c03b2

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