Johnson Memorial Cancer Center
Form 483 issued October 19, 2018 · Enfield, Connecticut
- Inspection
- Oct 1 – Oct 19, 2018
- Investigators
- Erik W. Koester· John P. Mistler
- Observations
- 6
- Pages
- 7
- FEI number
- 3010955218
In short: On October 19, 2018, FDA issued a Form 483 with 6 observations to Johnson Memorial Cancer Center in Enfield, Connecticut (FEI 3010955218) after an inspection that ran Oct 1 – Oct 19, 2018. The investigators were Erik W. Koester and John P. Mistler.
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…
- 02FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 03FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 04FDCA 501(a)(2)(A)
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) 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.
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Questions about this 483
What did FDA find at Johnson Memorial Cancer Center?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Johnson Memorial Cancer Center?
Erik W. Koester and John P. Mistler are named on this Form 483, for the inspection of Oct 1 – Oct 19, 2018. Each investigator has a profile showing what they cite most.
When was Johnson Memorial Cancer Center inspected by FDA?
The inspection ran Oct 1 – Oct 19, 2018, and the Form 483 is dated October 19, 2018.
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.