# FDA 483 - Madcar A Division of Century Direct Solutions - December 20, 2023

Source: https://www.globalkeysolutions.net/records/483/madcar-a-division-of-century-direct-solutions/98d7c9f6-1243-4df1-b762-690f9acdcf06

> FDA 483 for Madcar A Division of Century Direct Solutions on December 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Madcar A Division of Century Direct Solutions
- Inspection Date: 2023-12-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Madcar A Division of Century Direct Solutions, a human drug repackager in Islandia, NY, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of strict control over labeling operations, improper storage conditions for drug products, and failures in determining actual/theoretical yields. Additionally, the firm failed to record deviations from procedures and maintained deficient batch records.

## Related Officers

- [Amatul H. Marium](https://www.globalkeysolutions.net/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)

Company: https://www.globalkeysolutions.net/companies/madcar-a-division-of-century-direct-solutions/e0741b64-a273-4cd4-b6ea-aabc10d36d8a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961