RAM Pharma, Inc.
Form 483 issued August 1, 2019 · Idaho Falls, Idaho
- Inspection
- Jul 16 – Aug 1, 2019
- Investigator
- Bryan L. McGuckin
- Observations
- 7
- Pages
- 6
- FEI number
- 3012465222
In short: On August 1, 2019, FDA issued a Form 483 with 7 observations to RAM Pharma, Inc. in Idaho Falls, Idaho (FEI 3012465222) after an inspection that ran Jul 16 – Aug 1, 2019. The investigator was Bryan L. McGuckin. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.42
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 laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected RAM Pharma, Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Jul 16 – Aug 1, 2019. Each investigator has a profile showing what they cite most.
When was RAM Pharma, Inc. inspected by FDA?
The inspection ran Jul 16 – Aug 1, 2019, and the Form 483 is dated August 1, 2019.
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.