# FDA 483 - Granules Pharmaceuticals Inc. - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/granules-pharmaceuticals-inc/9fe1058e-33b6-49d9-9426-06f3421359e1

> FDA 483 for Granules Pharmaceuticals Inc. on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, revealed three significant observations related to manufacturing controls. The firm was cited for issues concerning equipment design and qualification, a lack of adequate written procedures for production and process controls, and incomplete master production and control records. One observation regarding equipment was a repeat finding from a previous inspection.

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## Related Officers

- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.globalkeysolutions.net/companies/granules-pharmaceuticals-inc/fa93bf3f-822e-47be-9e47-59b1c5446629

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e