# FDA 483 - Atlantic Biologicals - January 14, 2020

Source: https://www.keypedia.com/records/483/atlantic-biologicals/5b0c1839-5167-4738-9685-4f15de113c93

> FDA 483 for Atlantic Biologicals on January 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlantic Biologicals
- Inspection Date: 2020-01-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Atlantic Biologicals Corps, an own label distributor and warehouse in Miami, FL, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to maintain specifications, handle complaints, manage quarantined products, and ensure facility cleaning. Additionally, the firm failed to maintain calibration records for critical equipment, such as a refrigerator thermometer used for pharmaceutical products.

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/atlantic-biologicals/70d3e316-508c-4cfa-889f-65194b78cb30

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