# FDA 483 - Granules Pharmaceuticals Inc. - July 22, 2022

Source: https://www.globalkeysolutions.net/records/483/granules-pharmaceuticals-inc/8b164ba2-7c87-4681-bcc0-c7ba8f6d66e7

> FDA 483 for Granules Pharmaceuticals Inc. on July 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2022-07-22
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Granules Pharmaceuticals Inc. in Chantilly, VA, was inspected and cited for significant deficiencies in its drug manufacturing operations. The inspection revealed failures in quality control unit procedures, non-adherence to production and process control procedures, inadequately designed equipment, and insufficient investigations into major incidents. Additionally, the firm lacked proper procedures to prevent objectionable microorganisms and detailed sanitation methods.

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## Related Officers

- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64