# FDA 483 - Granules Pharmaceuticals Inc. - December 08, 2017

Source: https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/e578634c-c62f-4677-a1b5-a122bcb72b4d

> FDA 483 for Granules Pharmaceuticals Inc. on December 08, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2017-12-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Granules Pharmaceuticals Inc., a drug product manufacturer in Chantilly, VA, revealed deficiencies in its quality control unit. The firm failed to properly document corrective and preventative actions (CAPA) and did not adhere to its own procedures for the timely review of Standard Operating Procedures (SOPs). These findings indicate a lack of adherence to established quality system requirements.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)

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

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