Johnson Memorial Cancer Center
Form 483 issued August 5, 2014 · Enf i eld, Connecticut
- Inspection
- Jul 16 – Aug 5, 2014
- Investigators
- Mary McGarry· Ramon E. Martinez
- Observations
- 5
- Pages
- 5
- FEI number
- 3010955218
In short: On August 5, 2014, FDA issued a Form 483 with 5 observations to Johnson Memorial Cancer Center in Enf i eld, Connecticut (FEI 3010955218) after an inspection that ran Jul 16 – Aug 5, 2014. The investigators were Mary McGarry and Ramon E. Martinez. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The separate or defined areas and control systems necessary to prevent contamination…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Mary McGarry
3 documents · 2012–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
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 211.42(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Johnson Memorial Cancer Center?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Johnson Memorial Cancer Center?
Mary McGarry and Ramon E. Martinez are named on this Form 483, for the inspection of Jul 16 – Aug 5, 2014. Each investigator has a profile showing what they cite most.
When was Johnson Memorial Cancer Center inspected by FDA?
The inspection ran Jul 16 – Aug 5, 2014, and the Form 483 is dated August 5, 2014.
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.