PLZ Corp.
Form 483 issued June 7, 2019 · Mississauga, Canada
- Inspection
- Jun 3 – Jun 7, 2019
- Investigator
- Yumi J. Hiramine
- Observations
- 4
- Pages
- 3
- FEI number
- 3001956890
In short: On June 7, 2019, FDA issued a Form 483 with 4 observations to PLZ Corp. in Mississauga, Ontario (FEI 3001956890) after an inspection that ran Jun 3 – Jun 7, 2019. The investigator was Yumi J. Hiramine. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Input to and output from the computer and records or data are…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Routine calibration of mechanical equipment is not performed according to a written program designed…
This inspection in context
Yumi J. Hiramine
3 documents · 2015–2019
Cites 211.67(b) (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Canada.
The firmPLZ Corp. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PLZ Corp.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected PLZ Corp.?
Yumi J. Hiramine is named on this Form 483, for the inspection of Jun 3 – Jun 7, 2019. Each investigator has a profile showing what they cite most.
When was PLZ Corp. inspected by FDA?
The inspection ran Jun 3 – Jun 7, 2019, and the Form 483 is dated June 7, 2019.
How do I get the full Form 483 for PLZ Corp.?
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.