Granules Pharmaceuticals Inc.
Form 483 issued April 3, 2026 · Chantilly, Virginia
- Inspection
- Mar 30 – Apr 3, 2026
- Investigators
- David A. Oluwo· Ofuje D. Daniyan
- Observations
- 4
- Pages
- 5
- FEI number
- 3011585184
In short: On April 3, 2026, FDA issued a Form 483 with 4 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Mar 30 – Apr 3, 2026. The investigators were David A. Oluwo and Ofuje D. Daniyan. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The written stability testing…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Buildings used in the holding of a drug product are not maintained in a…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granules Pharmaceuticals Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
David A. Oluwo and Ofuje D. Daniyan are named on this Form 483, for the inspection of Mar 30 – Apr 3, 2026. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 30 – Apr 3, 2026, and the Form 483 is dated April 3, 2026.
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.