Company
MexicoSchwabe Mexico S.A. de C.V., Xochitepec, Mexico – FDA Inspections
Inspection records and compliance data for Schwabe Mexico S.A. de C.V. in Xochitepec. 2 FDA inspections on record, 1 Form 483, last inspected September 08, 2017.
Company Profile
This profile covers Schwabe Mexico S.A. de C.V. based in Xochitepec, Mexico.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 5, 2014. Last inspected September 8, 2017.
Most cited issue areas
- Acceptance of drug products1 inspection
- Component written specification1 inspection
- Lack of quality control unit1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 8, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1024500 |
| September 5, 2014 | NAI | Human Drugs · Drug Quality Assurance | 895257 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Schwabe Mexico S.A. de C.V.
FEI Number
3004120076
Address
Callejon Aguacate 4, Colonia Xochitepec Centro, Xochitepec, Mexico
Country
Mexico
ID: 38e17d25-edcc-4262-b95e-8f7fe23c54e0