Granules Pharmaceuticals Inc.
Form 483 issued December 15, 2023 · Chantilly, Virginia
- Inspection
- Dec 11 – Dec 15, 2023
- Investigators
- Azeezat M. Lawal· Yaharn Su
- Observations
- 5
- Pages
- 5
- FEI number
- 3011585184
In short: On December 15, 2023, FDA issued a Form 483 with 5 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Dec 11 – Dec 15, 2023. The investigators were Azeezat M. Lawal and Yaharn Su. Most observations concern facilities & equipment and quality system.
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Buildings used in the manufacturing, processing and holding of a drug product are not maintained in…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granules Pharmaceuticals Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
Azeezat M. Lawal and Yaharn Su are named on this Form 483, for the inspection of Dec 11 – Dec 15, 2023. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Dec 11 – Dec 15, 2023, and the Form 483 is dated December 15, 2023.
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.