Company
United StatesHydrofera, LLC, Manchester, CT – FDA Inspections
Inspection records and compliance data for Hydrofera, LLC in Manchester, Connecticut. 3 FDA inspections on record, 1 Form 483, last inspected August 23, 2017.
Company Profile
This profile covers Hydrofera, LLC based in Manchester, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 20, 2011. Last inspected August 23, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Equipment suitability & capability1 inspection
- Identification procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 23, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1025048 |
| September 4, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 846921 |
| July 20, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 735431 |
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
Hydrofera, LLC
FEI Number
3001236237
Address
340 Progress Dr, Manchester, Connecticut 06042, United States
Country
United States
ID: c4f73cb6-73ab-4aab-9fe2-914aff435aa2