FDA Inspection
Liebel-Flarsheim Company LLCLiebel-Flarsheim Company LLC – FDA Inspection, Nov 8, 2017
Record Details
This FDA Inspection record concerns Liebel-Flarsheim Company LLC, with an inspection on November 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 307e3276-4503-42c2-8aa7-1d7e087ed57b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031059
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.50(a)(2)Supplier oversight
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Liebel-Flarsheim Company LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 7, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 5, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Liebel-Flarsheim Company LLC
- FDA Inspection 933104 - 2015-07-07
- FDA Inspection 761168 - 2012-01-05
- FDA Inspection 700876 - 2010-12-08
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.