FDA Inspection
Summit Glove IncFDA Inspection 1054165 - Summit Glove Inc - May 31, 2018
Record Details
This FDA Inspection record concerns Summit Glove Inc, with an inspection on May 31, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Summit Glove Inc
- Inspection Date
- May 31, 2018
- Product Type
- Devices
View Company Profile
ID · 5a5597ef-d7a4-4950-97d3-d875ed4ac66c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054165
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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