RAM Pharma, Inc.
Form 483 issued February 7, 2017 · Idaho Falls, Idaho
- Inspection
- Feb 7, 2017
- Investigators
- Gary C. Pecic· Gerard P. De Leon· Lisa T. Michel
- Observations
- 13
- Pages
- 13
- FEI number
- 3012465222
In short: On February 7, 2017, FDA issued a Form 483 with 13 observations to RAM Pharma, Inc. in Idaho Falls, Idaho (FEI 3012465222) after an inspection that ran Feb 7, 2017. The investigators were Gary C. Pecic, Gerard P. De Leon, Lisa T. Michel and Tracy K. Li. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (3×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Gary C. Pecic
7 documents · 2015–2017
Cites 211.42 (design and construction features) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RAM Pharma, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected RAM Pharma, Inc.?
Gary C. Pecic, Gerard P. De Leon, Lisa T. Michel and Tracy K. Li are named on this Form 483, for the inspection of Feb 7, 2017. Each investigator has a profile showing what they cite most.
When was RAM Pharma, Inc. inspected by FDA?
The inspection ran Feb 7, 2017, and the Form 483 is dated February 7, 2017.
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.