Granules Pharmaceuticals Inc.
Form 483 issued July 22, 2022 · Chantilly, Virginia
- Inspection
- Jul 18 – Jul 22, 2022
- Investigator
- William Leonard
- Observations
- 6
- Pages
- 7
- FEI number
- 3011585184
In short: On July 22, 2022, FDA issued a Form 483 with 6 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Jul 18 – Jul 22, 2022. The investigator was William Leonard. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written production and process control procedures are not followed in the execution of production and. process…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granules Pharmaceuticals Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
William Leonard is named on this Form 483, for the inspection of Jul 18 – Jul 22, 2022. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jul 18 – Jul 22, 2022, and the Form 483 is dated July 22, 2022.
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.