Johnson Memorial Cancer Center
Form 483 issued October 21, 2021 · Enfield, Connecticut
- Inspection
- Sep 20 – Oct 21, 2021
- Investigator
- Jonathan G. Matrisciano
- Observations
- 4
- Pages
- 4
- FEI number
- 3010955218
In short: On October 21, 2021, FDA issued a Form 483 with 4 observations to Johnson Memorial Cancer Center in Enfield, Connecticut (FEI 3010955218) after an inspection that ran Sep 20 – Oct 21, 2021. The investigator was Jonathan G. Matrisciano. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (3×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate cleaning of work surfaces…
- 02FDCA 501(a)(2)(A)
Materials or supplies were not disinfected prior to entering…
- 03FDCA 501(a)(2)(A)
You had inadequate HEP A filter coverage and airflow over the area to which…
- 04
Disinfecting agents used in the ISO 5 classified aseptic processing…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmJohnson Memorial Cancer Center 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 Johnson Memorial Cancer Center?
FDA listed 4 observations on this Form 483, mostly about production. 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 Johnson Memorial Cancer Center?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Sep 20 – Oct 21, 2021. Each investigator has a profile showing what they cite most.
When was Johnson Memorial Cancer Center inspected by FDA?
The inspection ran Sep 20 – Oct 21, 2021, and the Form 483 is dated October 21, 2021.
How do I get the full Form 483 for Johnson Memorial Cancer 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.