L. Perrigo Co.
Form 483 issued November 7, 2008 · Allegan, Michigan
- Inspection
- Sep 15 – Nov 7, 2008
- Investigators
- Caroline H. Le· Patsy J. Domingo· Regina Brown
- Observations
- 10
- Pages
- 7
- FEI number
- 1811666
In short: On November 7, 2008, FDA issued a Form 483 with 10 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Sep 15 – Nov 7, 2008. The investigators were Caroline H. Le, Patsy J. Domingo and Regina Brown. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
6 of 10 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×) · 211.22(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 02
Written records of investigations into the failure of a batch or any of its components to…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Caroline H. Le
6 documents · 2008–2011
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L. Perrigo Co.?
FDA listed 10 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected L. Perrigo Co.?
Caroline H. Le, Patsy J. Domingo and Regina Brown are named on this Form 483, for the inspection of Sep 15 – Nov 7, 2008. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Sep 15 – Nov 7, 2008, and the Form 483 is dated November 7, 2008.
How do I get the full Form 483 for L. Perrigo Co.?
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