FDA Inspection
Pretika CorporationPretika Corporation – FDA Inspection, Oct 25, 2019
Record Details
This FDA Inspection record concerns Pretika Corporation, with an inspection on October 25, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pretika Corporation
- Inspection Date
- October 25, 2019
- Product Type
- Devices
View Company Profile
ID · 55227676-e61b-4807-bde3-d3dac736be92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1108019
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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