McNeil Healthcare, LLC
Form 483 issued August 6, 2008 · Las Piedras, Maryland
- Inspection
- Jul 22 – Aug 6, 2008
- Investigators
- Iraida Ortiz· Jorge L. Lajara
- Observations
- 2
- Pages
- 4
- FEI number
- 2650141
In short: On August 6, 2008, FDA issued a Form 483 with 2 observations to McNeil Healthcare, LLC in Las Piedras, Maryland (FEI 2650141) after an inspection that ran Jul 22 – Aug 6, 2008. The investigators were Iraida Ortiz and Jorge L. Lajara. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Established sampling plans and test procedures are not documented at…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Iraida Ortiz
2 documents · 2008
Cites 211.160 (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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Healthcare, LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected McNeil Healthcare, LLC?
Iraida Ortiz and Jorge L. Lajara are named on this Form 483, for the inspection of Jul 22 – Aug 6, 2008. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Jul 22 – Aug 6, 2008, and the Form 483 is dated August 6, 2008.
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.