L. Perrigo Co.
Form 483 issued August 10, 2005 · Holland, Michigan
- Inspection
- Aug 2 – Aug 10, 2005
- Investigator
- Patsy J. Domingo
- Observations
- 6
- Pages
- 3
- FEI number
- 1833336
In short: On August 10, 2005, FDA issued a Form 483 with 6 observations to L. Perrigo Co. in Holland, Michigan (FEI 1833336) after an inspection that ran Aug 2 – Aug 10, 2005. The investigator was Patsy J. Domingo. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established quality control…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Procedures describing the warehousing of drug…
- 04
Written records of major equipment cleaning, maintenance, and use are not included…
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 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L. Perrigo Co.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). 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 Aug 2 – Aug 10, 2005. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Aug 2 – Aug 10, 2005, and the Form 483 is dated August 10, 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.