FDA Inspection
Mariposa Labs, LLCMariposa Labs, LLC – FDA Inspection, Mar 30, 2018
Record Details
This FDA Inspection record concerns Mariposa Labs, LLC, with an inspection on March 30, 2018, issued by the Seattle District Office, covering animal drugs & feeds.
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ID · 6d561b5e-8313-4904-a9fd-d0d04dbfa01e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1046336
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.198(b)(1)Written complaint record must include
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Mariposa Labs, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2026 | Not classified | Seattle District Office | |
| November 22, 2013 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Mariposa Labs, LLC
- FDA Inspection 1341082 - 2026-09-02
- FDA Inspection 854757 - 2013-11-22
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