Company
United StatesHydroCision, Inc., North Billerica, MA – FDA Inspections
Inspection records and compliance data for HydroCision, Inc. in North Billerica, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected June 07, 2019.
Company Profile
This profile covers HydroCision, Inc. based in North Billerica, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 8, 2009. Last inspected June 7, 2019.
Most cited issue areas
- Design output - documentation1 inspection
- Documentation1 inspection
- Document review, approval documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 7, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1092412 |
| April 16, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 871352 |
| March 7, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 771019 |
| May 8, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 586534 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
HydroCision, Inc.
FEI Number
3003018854
Address
267 Boston Rd Bldg B Ste 28, North Billerica, Massachusetts 01862, United States
Country
United States
ID: 192c718e-48fb-4415-8315-96957041029b