Granules Pharmaceuticals Inc.
Form 483 issued January 17, 2020 · Chantilly, Virginia
- Investigator
- Sena G. Dissmeyer
- Observations
- 3
- Pages
- 3
- FEI number
- 3011585184
In short: On January 17, 2020, FDA issued a Form 483 with 3 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184). The investigator was Sena G. Dissmeyer. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
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
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Master production and control records lack complete manufacturing and control instructions and…
This inspection in context
Sena G. Dissmeyer
20 documents · 2017–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.63
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 production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
Sena G. Dissmeyer is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
This Form 483 is dated January 17, 2020.
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.