FDA Inspection 1118319 — Groupe Parima Inc.

Groupe Parima Inc. — FEI 3003773810

The FDA completed an inspection of Groupe Parima Inc. on Jan 24, 2020 in Saint-Laurent. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 24, 2020
Fiscal Year
2020
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Saint-Laurent (Canada)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
1594221 CFR 111.105(i)QC- required operations equipment, instruments, controls
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
438921 CFR 211.198(a)Procedures to be written and followed
440921 CFR 211.194(a)(4)Data secured in course of each test

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.