FDA Inspection
Globe Scientific LLCFDA Inspection 1181255 - Globe Scientific LLC - October 11, 2022
Record Details
This FDA Inspection record concerns Globe Scientific LLC, with an inspection on October 11, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Globe Scientific LLC
- Inspection Date
- October 11, 2022
- Product Type
- Devices
View Company Profile
ID · 7a2fb02a-10f5-4102-a35d-cf67f26b65d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1181255
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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