Company
MexicoProductos Roche S.A. de C. V., Toluca de Lerdo, Mexico – FDA Inspections
Inspection records and compliance data for Productos Roche S.A. de C. V. in Toluca de Lerdo. 5 FDA inspections on record, 1 Form 483, last inspected March 03, 2017.
Company Profile
This profile covers Productos Roche S.A. de C. V. based in Toluca de Lerdo, Mexico.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected October 23, 2009. Last inspected March 3, 2017.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Complete test data included in records1 inspection
- Extent of discrepancy, failure investigations1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 3, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1006760 |
| February 6, 2015 | VAI | Human Drugs · Drug Quality Assurance | 915946 |
| May 29, 2013 | NAI | Human Drugs · Drug Quality Assurance | 841985 |
| August 11, 2011 | NAI | Human Drugs · Drug Quality Assurance | 750346 |
| October 23, 2009 | NAI | Human Drugs · Drug Quality Assurance | 625472 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Productos Roche S.A. de C. V.
FEI Number
3003502861
Address
Isidro Fabela Norte No. 1536, Toluca de Lerdo, Mexico
Country
Mexico
ID: 1acdd170-e18f-4920-bd6d-517cf707d381