Company
MexicoBroncolin, S.A. de C.V., Ciudad De Mexico, Mexico – FDA Inspections
Inspection records and compliance data for Broncolin, S.A. de C.V. in Ciudad De Mexico. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected October 28, 2022.
Company Profile
This profile covers Broncolin, S.A. de C.V. based in Ciudad De Mexico, Mexico.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected November 9, 2012. Last inspected October 28, 2022.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Backup data not assured as exact and complete1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1182260 |
| February 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1002972 |
| November 9, 2012 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 806241 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Broncolin, S.A. de C.V.
FEI Number
3009331372
Address
Calle Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, Ciudad De Mexico, Mexico
Country
Mexico
ID: 3736d595-1510-4565-836d-4a763abe8299