RAM Pharma, Inc.
Form 483 issued December 17, 2021 · Idaho Falls, Idaho
- Inspection
- Nov 9 – Dec 17, 2021
- Investigators
- Kenneth O. Gee· Sangeeta M. Khurana
- Observations
- 7
- Pages
- 13
- FEI number
- 3012465222
In short: On December 17, 2021, FDA issued a Form 483 with 7 observations to RAM Pharma, Inc. in Idaho Falls, Idaho (FEI 3012465222) after an inspection that ran Nov 9 – Dec 17, 2021. The investigators were Kenneth O. Gee and Sangeeta M. Khurana. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
The flow of components, drug product containers, closures and in-process materials through the building is not…
This inspection in context
Kenneth O. Gee
9 documents · 2017–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmRAM Pharma, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RAM Pharma, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected RAM Pharma, Inc.?
Kenneth O. Gee and Sangeeta M. Khurana are named on this Form 483, for the inspection of Nov 9 – Dec 17, 2021. Each investigator has a profile showing what they cite most.
When was RAM Pharma, Inc. inspected by FDA?
The inspection ran Nov 9 – Dec 17, 2021, and the Form 483 is dated December 17, 2021.
How do I get the full Form 483 for RAM Pharma, 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.