L. Perrigo Co.
Form 483 issued December 15, 2006 · Allegan, Michigan
- Inspection
- Nov 7 – Dec 15, 2006
- Investigators
- Martha Sullivan Myrick· Patsy J. Domingo· Rebecca E. Dombrowski
- Observations
- 19
- Pages
- 10
- FEI number
- 1811666
In short: On December 15, 2006, FDA issued a Form 483 with 19 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Nov 7 – Dec 15, 2006. The investigators were Martha Sullivan Myrick, Patsy J. Domingo and Rebecca E. Dombrowski. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 12 of 19 observations.
Most cited: 21 CFR 211.192 (3×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Martha Sullivan Myrick
7 documents · 2005–2010
Cites 211.198 (complaint files) 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 19 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. 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.?
Martha Sullivan Myrick, Patsy J. Domingo and Rebecca E. Dombrowski are named on this Form 483, for the inspection of Nov 7 – Dec 15, 2006. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Nov 7 – Dec 15, 2006, and the Form 483 is dated December 15, 2006.
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.