Granules Pharmaceuticals Inc.
Form 483 issued June 25, 2021 · Chantilly, Virginia
- Inspection
- Jun 21 – Jun 25, 2021
- Investigators
- Karen A. Briggs· Sena G. Dissmeyer· Tekalign Wondimu
- Observations
- 2
- Pages
- 3
- FEI number
- 3011585184
In short: On June 25, 2021, FDA issued a Form 483 with 2 observations to Granules Pharmaceuticals Inc. in Chantilly, Virginia (FEI 3011585184) after an inspection that ran Jun 21 – Jun 25, 2021. The investigators were Karen A. Briggs, Sena G. Dissmeyer and Tekalign Wondimu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.67 (1×)
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…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
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 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Granules Pharmaceuticals Inc.?
Karen A. Briggs, Sena G. Dissmeyer and Tekalign Wondimu are named on this Form 483, for the inspection of Jun 21 – Jun 25, 2021. Each investigator has a profile showing what they cite most.
When was Granules Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jun 21 – Jun 25, 2021, and the Form 483 is dated June 25, 2021.
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.