Perrigo Holland Inc.
Form 483 issued October 22, 2019 · Holland, Michigan
- Inspection
- Oct 7 – Oct 22, 2019
- Investigators
- Charles L. Zhou· Lindsey M. Schwierjohann
- Observations
- 6
- Pages
- 5
- FEI number
- 1000518646
In short: On October 22, 2019, FDA issued a Form 483 with 6 observations to Perrigo Holland Inc. in Holland, Michigan (FEI 1000518646) after an inspection that ran Oct 7 – Oct 22, 2019. The investigators were Charles L. Zhou and Lindsey M. Schwierjohann. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the preparation of master production and control records are not described in a…
- 02
Written production and process control procedures are not documented at…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmPerrigo Holland Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Perrigo Holland Inc.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Perrigo Holland Inc.?
Charles L. Zhou and Lindsey M. Schwierjohann are named on this Form 483, for the inspection of Oct 7 – Oct 22, 2019. Each investigator has a profile showing what they cite most.
When was Perrigo Holland Inc. inspected by FDA?
The inspection ran Oct 7 – Oct 22, 2019, and the Form 483 is dated October 22, 2019.
How do I get the full Form 483 for Perrigo Holland Inc.?
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.