L. Perrigo Co.
Form 483 issued January 14, 2010 · Allegan, Michigan
- Inspection
- Nov 17, 2009 – Jan 14, 2010
- Investigators
- Constantin Y. Philopoulos· Jeffrey D. Meng· Patsy J. Domingo
- Observations
- 8
- Pages
- 8
- FEI number
- 1811666
In short: On January 14, 2010, FDA issued a Form 483 with 8 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Nov 17, 2009 – Jan 14, 2010. The investigators were Constantin Y. Philopoulos, Jeffrey D. Meng and Patsy J. Domingo. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
Quality system and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.170 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reserve drug product samples are not representative of each lot or…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Constantin Y. Philopoulos
9 documents · 2010–2021
Cites 211.42 (design and construction features) 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 211.170
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, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
Who inspected L. Perrigo Co.?
Constantin Y. Philopoulos, Jeffrey D. Meng and Patsy J. Domingo are named on this Form 483, for the inspection of Nov 17, 2009 – Jan 14, 2010. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Nov 17, 2009 – Jan 14, 2010, and the Form 483 is dated January 14, 2010.
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.