Granules Pharmaceuticals Inc.
Form 483 issued October 26, 2018 · Chantilly, Virginia
- Inspection
- Oct 22 – Oct 26, 2018
- Investigators
- Marcus A. Ray· Zhao Wang· Zhong Li
- Observations
- 2
- Pages
- 5
- FEI number
- 3011585184
In short: On October 26, 2018, FDA issued a Form 483 with 2 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Oct 22 – Oct 26, 2018. The investigators were Marcus A. Ray, Zhao Wang and Zhong Li. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granules Pharmaceuticals Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
Marcus A. Ray, Zhao Wang and Zhong Li are named on this Form 483, for the inspection of Oct 22 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Oct 22 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
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.