Roger Williams Medical Center
Form 483 issued August 14, 2019 · Providence, Rhode Island
- Inspection
- Jul 22 – Aug 14, 2019
- Investigators
- Jonah S. Ufferfilge· Jonathan G. Matrisciano
- Observations
- 7
- Pages
- 6
- FEI number
- 3013662663
In short: On August 14, 2019, FDA issued a Form 483 with 7 observations to Roger Williams Medical Center in Providence, Rhode Island (FEI 3013662663) after an inspection that ran Jul 22 – Aug 14, 2019. The investigators were Jonah S. Ufferfilge and Jonathan G. Matrisciano. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
Most cited: 21 CFR 211.113 (4×) · 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
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Your facility design allowed the influx of poor quality air into…
- 03
Your facility was designed and/or operated in a way that permits…
- 04
Disinfecting agents and cleaning pads used in the ISO 5 classified aseptic processing…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmRoger Williams Medical Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roger Williams Medical Center?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Roger Williams Medical Center?
Jonah S. Ufferfilge and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Jul 22 – Aug 14, 2019. Each investigator has a profile showing what they cite most.
When was Roger Williams Medical Center inspected by FDA?
The inspection ran Jul 22 – Aug 14, 2019, and the Form 483 is dated August 14, 2019.
How do I get the full Form 483 for Roger Williams Medical Center?
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.