Company
MexicoLaboratorios Sophia, S.A. De C.V., Zapopan, Mexico – FDA Inspections
Inspection records and compliance data for Laboratorios Sophia, S.A. De C.V. in Zapopan. 2 FDA inspections on record, 1 Form 483, last inspected December 14, 2018.
Company Profile
This profile covers Laboratorios Sophia, 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 August 28, 2015. Last inspected December 14, 2018.
Most cited issue areas
- Procedure Deviations Recorded and Justified1 inspection
- Procedures for sterile drug products1 inspection
- Quality control - supplier qualification1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1075932 |
| August 28, 2015 | VAI | Human Drugs · Drug Quality Assurance | 940164 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Laboratorios Sophia, S.A. De C.V.
FEI Number
1000310459
Address
Av. Paseo Del Norte No. 5255, Guadalajara Technology Park, Zapopan, Mexico
Country
Mexico
ID: 3dab6fc4-7b57-4598-bb9c-068678badd7a