Granules Pharmaceuticals Inc.
Form 483 issued August 21, 2019 · Chantilly, Virginia
- Inspection
- Aug 7 – Aug 21, 2019
- Investigator
- Craig D. Zagata
- Observations
- 2
- Pages
- 3
- FEI number
- 3011585184
In short: On August 21, 2019, FDA issued a Form 483 with 2 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Aug 7 – Aug 21, 2019. The investigator was Craig D. Zagata. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
2 of 2 observations on this 483 concern materials.
Most cited: 21 CFR 211.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Incoming components are not stored under quarantine until they have been tested or examined…
- 02
Written procedures are not followed for the storage of components, drug…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.80
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 materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
Craig D. Zagata is named on this Form 483, for the inspection of Aug 7 – Aug 21, 2019. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Aug 7 – Aug 21, 2019, and the Form 483 is dated August 21, 2019.
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.