FDA Inspection
Monarch Labs, LLCMonarch Labs, LLC – FDA Inspection, Jun 14, 2010
Record Details
This FDA Inspection record concerns Monarch Labs, LLC, with an inspection on June 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Monarch Labs, LLC
- Inspection Date
- June 14, 2010
- Product Type
- Devices
View Company Profile
ID · bba717a4-e29c-4de5-a9ae-71237e7e1749
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 666555
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Monarch Labs, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2024 | Not classified | Los Angeles District Office | |
| August 10, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 6, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 9, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Monarch Labs, LLC
- FDA Inspection 1233686 - 2024-02-13
- FDA Inspection 1178158 - 2022-08-10
- FDA Inspection 1050357 - 2018-03-06
- FDA Inspection 738542 - 2011-08-09
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