# FDA 483 - Granules Pharmaceuticals Inc. - January 28, 2022

Source: https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/47bd023e-5880-46d4-9c5a-5d1a6a31f0be

> FDA 483 for Granules Pharmaceuticals Inc. on January 28, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Granules Pharmaceuticals Inc.
- Inspection Date: 2022-01-28
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Granules Pharmaceuticals Inc, a drug manufacturer in Chantilly, VA, was cited with three observations during an FDA inspection. The firm failed to consistently follow established production and process control procedures, specifically regarding metal detection challenges. Additionally, the inspection revealed inadequate record-keeping for equipment cleaning and a lack of established and followed procedures for the cleaning and maintenance of equipment and the facility, leading to unsanitary conditions.

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## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)
- [Roseline N. Boateng](https://www.keypedia.com/people/roseline-n-boateng/81c4fa2a-1f0b-4e13-ba45-39ca7a07d3b3)

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

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