Company
MexicoGelpharma S.A. de C.V., Zapopan, Mexico – FDA Inspections
Inspection records and compliance data for Gelpharma S.A. de C.V. in Zapopan. 2 FDA inspections on record, 1 Form 483, last inspected December 09, 2016.
Company Profile
This profile covers Gelpharma S.A. de C.V. based in Zapopan, Mexico.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected October 8, 2014. Last inspected December 9, 2016.
Most cited issue areas
- Backup data not assured as exact and complete1 inspection
- Batch record - results; monitoring1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 9, 2016 | VAI | Human Drugs · Drug Quality Assurance | 1005806 |
| October 8, 2014 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 907061 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gelpharma S.A. de C.V.
FEI Number
3010158287
Address
Av. Paseo Del Pacifico No. 380 Guadalajara Technology Park, Zapopan, Zapopan, Mexico
Country
Mexico
ID: 52ecc986-8d04-44db-ac9f-ea708ba38969