McNeil Healthcare, LLC
Form 483 issued February 13, 2001 · Las Piedras, Maryland
- Inspection
- Jan 23 – Feb 13, 2000
- Investigators
- Jorge L. Guadalupe· Marianela Aponte
- Observations
- 4
- Pages
- 1
- FEI number
- 2650141
In short: On February 13, 2001, FDA issued a Form 483 with 4 observations to McNeil Healthcare, LLC in Las Piedras, Maryland (FEI 2650141) after an inspection that ran Jan 23 – Feb 13, 2000. The investigators were Jorge L. Guadalupe and Marianela Aponte. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The finn's Installation and Operational Qualification report of the Waters Millennium 32 HPLC Computer System does…
This inspection in context
Jorge L. Guadalupe
1 document · 2001
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Healthcare, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected McNeil Healthcare, LLC?
Jorge L. Guadalupe and Marianela Aponte are named on this Form 483, for the inspection of Jan 23 – Feb 13, 2000. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Jan 23 – Feb 13, 2000, and the Form 483 is dated February 13, 2001.
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.