FDA Inspection
SourceMark, LLCSourceMark, LLC – FDA Inspection, May 13, 2014
Record Details
This FDA Inspection record concerns SourceMark, LLC, with an inspection on May 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SourceMark, LLC
- Inspection Date
- May 13, 2014
- Product Type
- Devices
View Company Profile
ID · a5535ca6-a110-46de-9e63-b6d6602c1f46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 879049
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.40(a)Report of death, injury
- 21 CFR 803.17Lack of Written MDR Procedures
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