FDA Inspection
Inter-Med LlcInter-Med Llc – FDA Inspection, Apr 29, 2016
Record Details
This FDA Inspection record concerns Inter-Med Llc, with an inspection on April 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inter-Med Llc
- Inspection Date
- April 29, 2016
- Product Type
- Devices
View Company Profile
ID · 7e77017d-82bc-4f51-902a-f230fc5401d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 977542
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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