FDA Inspection
Compression Solutions LLCCompression Solutions LLC – FDA Inspection, Jun 13, 2013
Record Details
This FDA Inspection record concerns Compression Solutions LLC, with an inspection on June 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Compression Solutions LLC
- Inspection Date
- June 13, 2013
- Product Type
- Devices
View Company Profile
ID · 68499a68-551d-424d-a7ee-1204071e7435
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836175
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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