FDA Inspection
Precision Herbs LLCPrecision Herbs LLC – FDA Inspection, Oct 14, 2009
Record Details
This FDA Inspection record concerns Precision Herbs LLC, with an inspection on October 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Precision Herbs LLC
- Inspection Date
- October 14, 2009
- Product Type
- Devices
View Company Profile
ID · e8fe5e63-8acb-4fe0-9133-ea98e3bc549f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 619951
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
14- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 820.198(a)General
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 806.30Access not permitted
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.194(a)(6)Test results, comparison with standards not included
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(e)Quality System Procedures
Showing 10 of 14 citations.
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.