McNeil Healthcare, LLC
Form 483 issued February 3, 2010 · Las Piedras, Maryland
- Inspection
- Jan 28 – Feb 3, 2010
- Investigator
- Ramon A. Hernandez
- Observations
- 1
- Pages
- 1
- FEI number
- 2650141
In short: On February 3, 2010, FDA issued a Form 483 with 1 observation to McNeil Healthcare, LLC in Las Piedras, Maryland (FEI 2650141) after an inspection that ran Jan 28 – Feb 3, 2010. The investigator was Ramon A. Hernandez. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Ramon A. Hernandez
2 documents · 2010–2011
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in Maryland.
The firmMcNeil Healthcare, LLC history
All 12 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Healthcare, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected McNeil Healthcare, LLC?
Ramon A. Hernandez is named on this Form 483, for the inspection of Jan 28 – Feb 3, 2010. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Jan 28 – Feb 3, 2010, and the Form 483 is dated February 3, 2010.
How do I get the full Form 483 for McNeil Healthcare, LLC?
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.