# FDA 483 - Continental Services Group, Inc. - May 31, 2019

Source: https://www.globalkeysolutions.net/records/483/continental-services-group-inc/a8f9cea7-4c61-4432-ab85-29aed63ca20b

> FDA 483 for Continental Services Group, Inc. on May 31, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Continental Services Group, Inc.
- Inspection Date: 2019-05-31
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Continental Services Group, Inc., a blood and source plasma donor center in Ft Lauderdale, FL, revealed significant deficiencies in their written standard operating procedures. The firm failed to establish and follow SOPs for calibrating blood pressure monitors, detailing physical exams for plasma donors, and properly documenting donor screening observations. These issues indicate a lack of adequate controls over critical aspects of blood and blood component collection.

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## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Ivan E. Reyes](https://www.globalkeysolutions.net/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)

Company: https://www.globalkeysolutions.net/companies/continental-services-group-inc/72358f1d-9b15-4d27-87c5-434e7b5f27d1

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