Industria Farmaceutica Andromaco S.A. de C.V., Zona Industrial Parque Industrial Toluca 2000, Mexico – FDA Inspections
Inspection records and compliance data for Industria Farmaceutica Andromaco S.A. de C.V. in Zona Industrial Parque Industrial Toluca 2000. 4 FDA inspections on record, 1 Form 483, last inspected February 01, 2019.
This profile covers Industria Farmaceutica Andromaco S.A. de C.V. based in Zona Industrial Parque Industrial Toluca 2000, Mexico.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 1, 2012. Last inspected February 1, 2019.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Procedures not in writing, fully followed2 inspections
- Valid stability test methods2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 1, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1078693 |
| February 1, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1042708 |
| October 30, 2015 | VAI | Human Drugs · Drug Quality Assurance | 953016 |
| June 1, 2012 | VAI | Human Drugs · Drug Quality Assurance | 786248 |
No Form 483s, Warning Letters or EIRs on record.
Companies with similar regulatory profiles, compliance history, and operations.
Name
Industria Farmaceutica Andromaco S.A. de C.V.
FEI Number
3000223220
Address
Calle Eje 3 Norte No. 202 Parque Industrial Toluca 2000, Zona Industrial Parque Industrial Toluca 2000, Mexico
Country
Mexico
ID: 316a0fba-84d0-4f81-abe3-edd660991b0c