McNeil Healthcare, LLC
Form 483 issued November 2, 2010 · Las Piedras, Maryland
- Inspection
- Sep 20 – Nov 2, 2010
- Investigator
- Jose R. Lopez
- Observations
- 6
- Pages
- 10
- FEI number
- 2650141
In short: On November 2, 2010, FDA issued a Form 483 with 6 observations to McNeil Healthcare, LLC in Las Piedras, Maryland (FEI 2650141) after an inspection that ran Sep 20 – Nov 2, 2010. The investigator was Jose R. Lopez. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures for the review of any unexplained discrepancy or the failure of a batch or any…
- 03
Drug products failing to meet established specifications are not identified and controlled to prevent the approval…
- 04
The stability program for drug products does not include sample size based on statistical criteria for…
This inspection in context
Jose R. Lopez
7 documents · 2010–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Healthcare, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected McNeil Healthcare, LLC?
Jose R. Lopez is named on this Form 483, for the inspection of Sep 20 – Nov 2, 2010. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Sep 20 – Nov 2, 2010, and the Form 483 is dated November 2, 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.