Marlborough Hospital
Form 483 issued September 17, 2014 · Marlborough, Maryland
- Inspection
- Sep 8 – Sep 17, 2014
- Investigator
- Mary McGarry
- Observations
- 3
- Pages
- 3
- FEI number
- 1270482
In short: On September 17, 2014, FDA issued a Form 483 with 3 observations to Marlborough Hospital in Marlborough, Maryland (FEI 1270482) after an inspection that ran Sep 8 – Sep 17, 2014. The investigator was Mary McGarry. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 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
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
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 firmMarlborough Hospital history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Marlborough Hospital?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. 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 Marlborough Hospital?
Mary McGarry is named on this Form 483, for the inspection of Sep 8 – Sep 17, 2014. Each investigator has a profile showing what they cite most.
When was Marlborough Hospital inspected by FDA?
The inspection ran Sep 8 – Sep 17, 2014, and the Form 483 is dated September 17, 2014.
How do I get the full Form 483 for Marlborough Hospital?
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.