FDA Inspection
Lymol Medical CorporationLymol Medical Corporation – FDA Inspection, Jul 29, 2021
Record Details
This FDA Inspection record concerns Lymol Medical Corporation, with an inspection on July 29, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lymol Medical Corporation
- Inspection Date
- July 29, 2021
- Product Type
- Devices
View Company Profile
ID · 7392a612-994e-427e-bbe8-61ba5300ed8d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1147369
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lymol Medical Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2020 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2011 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| September 14, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lymol Medical Corporation
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.