Company
United States9mm Special Effects, Haiku, HI – FDA Inspections
Inspection records and compliance data for 9mm Special Effects in Haiku, Hawaii. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected September 30, 2014.
Company Profile
This profile covers 9mm Special Effects based in Haiku, Hawaii, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected September 30, 2014.
Most cited issue areas
- Design control - no procedures1 inspection
- DMR - not or inadequately maintained1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 30, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 899273 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
9mm Special Effects
FEI Number
3009537647
Address
465 Haiku Rd, Haiku, Hawaii 96708, United States
Country
United States
ID: d85e27df-26af-4f3c-a094-2b40bb9b9598