Granules Pharmaceuticals Inc.
Form 483 issued January 28, 2022 · Chantilly, Virginia
- Inspection
- Jan 24 – Jan 28, 2022
- Investigators
- Roseline N. Boateng· William Leonard
- Observations
- 3
- Pages
- 4
- FEI number
- 3011585184
In short: On January 28, 2022, FDA issued a Form 483 with 3 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Jan 24 – Jan 28, 2022. The investigators were Roseline N. Boateng and William Leonard. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Records are not kept for the cleaning…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Roseline N. Boateng
4 documents · 2019–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Maryland.
The firmGranules Pharmaceuticals Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granules Pharmaceuticals Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
Roseline N. Boateng and William Leonard are named on this Form 483, for the inspection of Jan 24 – Jan 28, 2022. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jan 24 – Jan 28, 2022, and the Form 483 is dated January 28, 2022.
How do I get the full Form 483 for Granules Pharmaceuticals Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.