FDA Inspection
Brammer Bio, LLCBrammer Bio, LLC – FDA Inspection, Mar 18, 2015
Record Details
This FDA Inspection record concerns Brammer Bio, LLC, with an inspection on March 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brammer Bio, LLC
- Inspection Date
- March 18, 2015
- Product Type
- Devices
View Company Profile
ID · 8ed6fab3-acf3-4f9a-a2b7-da8627a7d1e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918946
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.