# FDA 483 - Granules Pharmaceuticals Inc. - October 26, 2018

Source: https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/c226dccf-c3be-4513-9d02-7e866eb3fb84

> FDA 483 for Granules Pharmaceuticals Inc. on October 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2018-10-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Granules Pharmaceuticals Inc. in Chantilly, VA, a drug manufacturer, received two observations during an FDA inspection. The firm was cited for not having all manufacturing equipment for commercial products installed and qualified. Additionally, laboratory controls were found deficient due to the use of an analytical reagent with an unsupported expiration date for testing multiple drug products.

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## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)
- [Amy Wang](https://www.keypedia.com/people/amy-wang/fefe516e-9daf-4040-a475-5aca24756468)

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