L. Perrigo Co.
Form 483 issued January 17, 2019 · Allegan, Michigan
- Inspection
- Jan 7 – Jan 17, 2019
- Investigator
- Emily J. Orban
- Observations
- 8
- Pages
- 8
- FEI number
- 1811666
In short: On January 17, 2019, FDA issued a Form 483 with 8 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Jan 7 – Jan 17, 2019. The investigator was Emily J. Orban. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 02
Procedures for the preparation of master production and control records are not described in a…
- 03
BUPLOYEE(S) SIGNATURE DATEISSUED The written stability program for drug products does not include reliable, meaningful…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Emily J. Orban
19 documents · 2012–2020
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 211.113(a)
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 laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected L. Perrigo Co.?
Emily J. Orban is named on this Form 483, for the inspection of Jan 7 – Jan 17, 2019. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Jan 7 – Jan 17, 2019, and the Form 483 is dated January 17, 2019.
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.