Rocky Mountain Pharmacy Inc.
Form 483 issued March 13, 2018 · Bozeman, Montana
- Inspection
- Mar 6 – Mar 13, 2018
- Investigator
- Nayan J. Patel
- Observations
- 2
- Pages
- 1
- FEI number
- 3013935808
In short: On March 13, 2018, FDA issued a Form 483 with 2 observations to Rocky Mountain Pharmacy Inc. in Bozeman, Montana (FEI 3013935808) after an inspection that ran Mar 6 – Mar 13, 2018. The investigator was Nayan J. Patel. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 1 system, led by materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
The firmRocky Mountain Pharmacy 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rocky Mountain Pharmacy Inc.?
FDA listed 2 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Rocky Mountain Pharmacy Inc.?
Nayan J. Patel is named on this Form 483, for the inspection of Mar 6 – Mar 13, 2018. Each investigator has a profile showing what they cite most.
When was Rocky Mountain Pharmacy Inc. inspected by FDA?
The inspection ran Mar 6 – Mar 13, 2018, and the Form 483 is dated March 13, 2018.
How do I get the full Form 483 for Rocky Mountain Pharmacy 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.