FDA Inspection
Lechnologies Research, Inc.Lechnologies Research, Inc. – FDA Inspection, Mar 24, 2010
Record Details
This FDA Inspection record concerns Lechnologies Research, Inc., with an inspection on March 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lechnologies Research, Inc.
- Inspection Date
- March 24, 2010
- Product Type
- Devices
View Company Profile
ID · 86508cfe-3c6f-47de-b55c-f0d97194deeb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 806.20(b)(5)Records of communications
- 21 CFR 820.198(a)General
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(b)Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lechnologies Research, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lechnologies Research, Inc.
- FDA Inspection 749549 - 2011-10-14
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.