McNeil Healthcare, LLC
Form 483 issued September 9, 2002 · Las Piedras, Maryland
- Inspection
- Aug 20 – Sep 9, 2002
- Investigator
- Ileana Barreto-Pettit
- Observations
- 5
- Pages
- 3
- FEI number
- 2650141
In short: On September 9, 2002, FDA issued a Form 483 with 5 observations to McNeil Healthcare, LLC in Las Piedras, Maryland (FEI 2650141) after an inspection that ran Aug 20 – Sep 9, 2002. The investigator was Ileana Barreto-Pettit. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and production account for 4 of 5 observations.
Most cited: 21 CFR 211.100 (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 are…
- 02
Deviations from written sampling…
- 03
Written records of investigations into the failure of a batch or any of its components to…
- 04
Changes to written procedures are not reviewed and approved by…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Healthcare, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected McNeil Healthcare, LLC?
Ileana Barreto-Pettit is named on this Form 483, for the inspection of Aug 20 – Sep 9, 2002. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Aug 20 – Sep 9, 2002, and the Form 483 is dated September 9, 2002.
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.