Granules Pharmaceuticals Inc.
FDA inspection history in Chantilly, Virginia, 2017 to 2026
- 9
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2018: one Form 483; 2019: one Form 483; 2020: one Form 483; 2021: one Form 483; 2022: two Form 483s; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–23Eight Form 483s, at Chantilly, Virginia.
- 2022The longest 483 on file: 6 observations over 7 pages at Chantilly, Virginia.
- 2026One Form 483, at Chantilly, Virginia.
Cited most
Across all Granules Pharmaceuticals observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.63Equipment design, size, and location4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
The complete Granules Pharmaceuticals file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Chantilly, Virginia
Nine Form 483s · 2017 to 2026 · 28 observations
Latest: Form 483, Apr 3, 2026 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-03 | 483 Form 483 | Chantilly, Virginia | 4 | $99 |
| 2023-12-15 | 483 Form 483 | Chantilly, Virginia | 5 | $99 |
| 2022-07-22 | 483 Form 483 | Chantilly, Virginia | 6 | $99 |
| 2022-01-28 | 483 Form 483 | Chantilly, Virginia | 3 | $99 |
| 2021-06-25 | 483 Form 483 | Chantilly, Virginia | 2 | $99 |
| 2020-01-17 | 483 Form 483 | Chantilly, Virginia | 3 | $99 |
| 2019-08-21 | 483 Form 483 | Chantilly, Virginia | 2 | $99 |
| 2018-10-26 | 483 Form 483 | Chantilly, Virginia | 2 | $99 |
| 2017-12-08 | 483 Form 483 | Chantilly, Virginia | 1 | $99 |
Investigators on these documents
Sena G. Dissmeyer (2)Craig D. Zagata (2)William Leonard (2)Marcus A. Ray (1)Ofuje D. Daniyan (1)Roseline N. Boateng (1)Tekalign Wondimu (1)Yaharn Su (1)Zhao Wang (1)Azeezat M. Lawal (1)Zhong Li (1)David A. Oluwo (1)
FEI number 3011585184 · most recent document Apr 3, 2026
About Granules Pharmaceuticals Inc.
How many FDA Form 483s has Granules Pharmaceuticals Inc. received?
FDA Intel has 9 Form 483s on file for Granules Pharmaceuticals Inc.; the most recent is dated Apr 3, 2026.
When was Granules Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Granules Pharmaceuticals Inc. is a Form 483 dated Apr 3, 2026, for the site in Chantilly, Virginia.
What did FDA cite at Granules Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Granules Pharmaceuticals Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.63 (Equipment design, size, and location), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.