Company
IndiaGPC Medical Ltd., Loni, India – FDA Inspections
Inspection records and compliance data for GPC Medical Ltd. in Loni. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected October 24, 2019.
Company Profile
This profile covers GPC Medical Ltd. based in Loni, India.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected March 3, 2011. Last inspected October 24, 2019.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate In-process acceptance procedures1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 24, 2019 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1110930 |
| June 22, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1015651 |
| March 3, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 716226 |
FDA documents
Form 483s (2)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
GPC Medical Ltd.
FEI Number
3006513362
Address
Plot C-3, Sec B-1, UPSIDC, Trans Delhi Signature City, Loni,, Loni, India
Country
India
ID: a667acd0-d288-4c53-9f7d-76fcd15fb830