FDA Inspection
LC Medical Concepts, IncLC Medical Concepts, Inc – FDA Inspection, Oct 23, 2018
Record Details
This FDA Inspection record concerns LC Medical Concepts, Inc, with an inspection on October 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 43e56844-0308-408f-a0ff-5a46110893d5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069947
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LC Medical Concepts, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for LC Medical Concepts, Inc
- FDA Inspection 1119092 - 2020-02-25
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.