FDA Inspection
Sky Medical Supplies and Equipments, LLCSky Medical Supplies and Equipments, LLC – FDA Inspection, Sep 17, 2021
Record Details
This FDA Inspection record concerns Sky Medical Supplies and Equipments, LLC, with an inspection on September 17, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 17, 2021
- Product Type
- Devices
View Company Profile
ID · 04913ee1-a074-4dd9-b6db-14e5643e23ea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152929
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 803.17Lack of Written MDR Procedures
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.