Company
United States2035 PMA, Rapid City, SD – FDA Inspections
Inspection records and compliance data for 2035 PMA in Rapid City, South Dakota. 4 FDA inspections on record (4 OAI), last inspected August 13, 2015.
Company Profile
This profile covers 2035 PMA based in Rapid City, South Dakota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 4
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected May 27, 2010. Last inspected August 13, 2015.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Design control - no procedures1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 13, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 941431 |
| April 3, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 921358 |
| September 13, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 847869 |
| May 27, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 665333 |
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
2035 PMA
FEI Number
3004022340
Address
2216 Cedar Dr, Rapid City, South Dakota 57702, United States
Country
United States
ID: aacc6bc4-364b-4e89-8c13-c15e90c1dba8