Company
United StatesA Cute Baby, Inc., Orem, UT – FDA Inspections
Inspection records and compliance data for A Cute Baby, Inc. in Orem, Utah. 1 FDA inspection on record, 1 Form 483, last inspected December 07, 2017.
Company Profile
This profile covers A Cute Baby, Inc. based in Orem, Utah, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected December 7, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Servicing - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 7, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1034509 |
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
A Cute Baby, Inc.
FEI Number
3009243271
Address
865 N 1430 W, Orem, Utah 84057, United States
Country
United States
ID: 08558004-2835-4857-9f30-ed033bdfa640