FDA Inspection
Groupe Parima Inc.Groupe Parima Inc. – FDA Inspection, Aug 25, 2023
Record Details
This FDA Inspection record concerns Groupe Parima Inc., with an inspection on August 25, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 09910123-b3ee-4926-a80a-81980917b7a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215880
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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Other FDA inspections of Groupe Parima Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2020 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 27, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Groupe Parima Inc.
- FDA Inspection 1118319 - 2020-01-24
- FDA Inspection 1049889 - 2018-04-27
- FDA Inspection 964127 - 2016-01-22
- FDA Inspection 848381 - 2013-08-30
- FDA Inspection 746755 - 2011-09-13
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