Raining Rose, Inc.
Form 483 issued January 24, 2020 · Cedar Rapids, Iowa
- Investigator
- Wayne D. McGrath
- Observations
- 3
- Pages
- 3
- FEI number
- 3003031992
In short: On January 24, 2020, FDA issued a Form 483 with 3 observations to Raining Rose, Inc. in Cedar Rapids, Iowa (FEI 3003031992). The investigator was Wayne D. McGrath. Most observations concern materials and packaging & labeling.
At a glance
Materials and packaging & labeling account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Access to the storage area for labels and labeling materials is not…
- 03
Equipment and utensils are not at appropriate intervals to prevent that would alter the safety, identity…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmRaining Rose, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Raining Rose, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Raining Rose, Inc.?
Wayne D. McGrath is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Raining Rose, Inc. inspected by FDA?
This Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Raining Rose, 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.