Company
United StatesMonarch Labs, LLC, Irvine, CA – FDA Inspections
Inspection records and compliance data for Monarch Labs, LLC in Irvine, California. 5 FDA inspections on record (1 OAI), last inspected February 13, 2024.
Company Profile
This profile covers Monarch Labs, LLC based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 14, 2010. Last inspected February 13, 2024.
Most cited issue areas
- DMR - not or inadequately maintained1 inspection
- Documentation1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2024 | Not classified | Medical Devices & Rad Health | 1233686 |
| August 10, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1178158 |
| March 6, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1050357 |
| August 9, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 738542 |
| June 14, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 666555 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Monarch Labs, LLC
FEI Number
3005735989
Address
17875 Sky Park Cir Ste K, Irvine, California 92614, United States
Country
United States
ID: ca9d1b7f-ba49-48a3-b664-cc022bb42516