L. Perrigo Co.
Form 483 issued September 13, 2007 · Allegan, Michigan
- Inspection
- Sep 5 – Sep 13, 2007
- Investigator
- Patsy J. Domingo
- Observations
- 2
- Pages
- 2
- FEI number
- 1811666
In short: On September 13, 2007, FDA issued a Form 483 with 2 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Sep 5 – Sep 13, 2007. The investigator was Patsy J. Domingo. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
2 of 2 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.122 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in…
- 02
Written procedures for the sampling of packaging and labeling…
This inspection in context
Patsy J. Domingo
15 documents · 2005–2010
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmL. Perrigo Co. history
All 14 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.122
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L. Perrigo Co.?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected L. Perrigo Co.?
Patsy J. Domingo is named on this Form 483, for the inspection of Sep 5 – Sep 13, 2007. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Sep 5 – Sep 13, 2007, and the Form 483 is dated September 13, 2007.
How do I get the full Form 483 for L. Perrigo Co.?
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.