Groupe PARIMA Inc.
Form 483 issued April 27, 2018 · Montreal, Canada
- Inspection
- Apr 23 – Apr 27, 2018
- Investigator
- Brett R. Havranek
- Observations
- 3
- Pages
- 6
- FEI number
- 3003773810
In short: On April 27, 2018, FDA issued a Form 483 with 3 observations to Groupe PARIMA Inc. in Montreal, Quebec (FEI 3003773810) after an inspection that ran Apr 23 – Apr 27, 2018. The investigator was Brett R. Havranek. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
- 02
Routine checking of mechanical equipment is not performed according to a written program designed…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
This inspection in context
Brett R. Havranek
6 documents · 2015–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
The firmGroupe PARIMA Inc. history
The site's inspection history, in date order.
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 Groupe PARIMA Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. 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 Groupe PARIMA Inc.?
Brett R. Havranek is named on this Form 483, for the inspection of Apr 23 – Apr 27, 2018. Each investigator has a profile showing what they cite most.
When was Groupe PARIMA Inc. inspected by FDA?
The inspection ran Apr 23 – Apr 27, 2018, and the Form 483 is dated April 27, 2018.
How do I get the full Form 483 for Groupe PARIMA 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.