Raining Rose, Inc.
Form 483 issued February 7, 2025 · Cedar Rapids, Iowa
- Inspection
- Feb 3 – Feb 7, 2025
- Investigator
- Melissa M. Steiger
- Observations
- 5
- Pages
- 6
- FEI number
- 3003031992
In short: On February 7, 2025, FDA issued a Form 483 with 5 observations to Raining Rose, Inc. in Cedar Rapids, Iowa (FEI 3003031992) after an inspection that ran Feb 3 – Feb 7, 2025. The investigator was Melissa M. Steiger. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Any building used in the manufacture, processing, packing, or holding of a drug product shall be…
- 02
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
There shall be a quality control unit that shall have the responsibility and authority to approve…
This inspection in context
Melissa M. Steiger
7 documents · 2024–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Michigan.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Raining Rose, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Raining Rose, Inc.?
Melissa M. Steiger is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was Raining Rose, Inc. inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2025, and the Form 483 is dated February 7, 2025.
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.