FDA Inspection
Pharma Systems Eesti OUPharma Systems Eesti OU – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns Pharma Systems Eesti OU, with an inspection on February 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pharma Systems Eesti OU
- Inspection Date
- February 19, 2016
- Product Type
- Devices
View Company Profile
ID · a80a3796-4384-4151-8c08-c1343c724186
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960444
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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