Company
United StatesBioSerenity USA, Inc., Glen Burnie, MD – FDA Inspections
Inspection records and compliance data for BioSerenity USA, Inc. in Glen Burnie, Maryland. 3 FDA inspections on record, last inspected September 06, 2016.
Company Profile
This profile covers BioSerenity USA, Inc. based in Glen Burnie, Maryland, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 5, 2010. Last inspected September 6, 2016.
Most cited issue areas
- Analysis of data/reports from data sources1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
- Statistical techniques - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 6, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 985197 |
| February 5, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 866425 |
| January 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 633707 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
BioSerenity USA, Inc.
FEI Number
3005908471
Address
801 Cromwell Park Dr Ste 108, Glen Burnie, Maryland 21061, United States
Country
United States
ID: a9bff44c-c77e-4300-9270-6705c839e164