FDA Inspection
Maco BagMaco Bag – FDA Inspection, Oct 13, 2022
Record Details
This FDA Inspection record concerns Maco Bag, with an inspection on October 13, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maco Bag
- Inspection Date
- October 13, 2022
- Product Type
- Devices
View Company Profile
ID · fd83f305-b691-4d5b-bb2e-5a9b7899f79d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1181447
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Maco Bag
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 11, 2016 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Maco Bag
- FDA Inspection 1079361 - 2019-02-01
- FDA Inspection 958089 - 2016-01-11
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