L. Perrigo Co.
Form 483 issued July 28, 2005 · Allegan, Michigan
- Inspection
- Jul 19 – Jul 28, 2005
- Investigator
- Martha Sullivan Myrick
- Observations
- 8
- Pages
- 4
- FEI number
- 1811666
In short: On July 28, 2005, FDA issued a Form 483 with 8 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Jul 19 – Jul 28, 2005. The investigator was Martha Sullivan Myrick. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
8 of 8 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (7×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of all written and oral complaints regarding a drug…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Complaint records are deficient in that they do not document the reason and the individual making…
- 04
Complaint records are deficient in that they do not include the known…
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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L. Perrigo Co.?
FDA listed 8 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected L. Perrigo Co.?
Martha Sullivan Myrick is named on this Form 483, for the inspection of Jul 19 – Jul 28, 2005. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Jul 19 – Jul 28, 2005, and the Form 483 is dated July 28, 2005.
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.