Company
MexicoGreatbatch Medical S. De R.L. De C.V., Tijuana, Mexico – FDA Inspections
Inspection records and compliance data for Greatbatch Medical S. De R.L. De C.V. in Tijuana. 3 FDA inspections on record, 2 Form 483s, last inspected February 02, 2023.
Company Profile
This profile covers Greatbatch Medical S. De R.L. De C.V. based in Tijuana, Mexico.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 26, 2018. Last inspected February 2, 2023.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1199725 |
| August 15, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1099650 |
| July 26, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1062662 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Greatbatch Medical S. De R.L. De C.V.
FEI Number
3007882731
Address
Boulevard Licenciado Hector Teran Teran 20120, Parque Industrial Ciudad Industrial, Tijuana, Tijuana, Mexico
Country
Mexico
ID: d99c9bd8-e056-4cb2-85b8-5c6d7df1c41c