Company
Dominican Republic (the)Laboratorio Magnachem International, S.A., Haina, Dominican Republic (the) – FDA Inspections
Inspection records and compliance data for Laboratorio Magnachem International, S.A. in Haina. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected November 10, 2023.
Company Profile
This profile covers Laboratorio Magnachem International, S.A. based in Haina, Dominican Republic (the).
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected April 27, 2012. Last inspected November 10, 2023.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Control procedures to monitor and validate performance1 inspection
- Following/documenting laboratory controls1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 10, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1224442 |
| June 2, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1015500 |
| September 16, 2014 | VAI | Human Drugs · Drug Quality Assurance | 895604 |
| April 27, 2012 | VAI | Human Drugs · Drug Quality Assurance | 782783 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Laboratorio Magnachem International, S.A.
FEI Number
3003320065
Address
Esq Calle K, Ave Jose Francisco Pena Gomez, Haina, Dominican Republic (the)
Country
Dominican Republic (the)
ID: 4690f0a4-618f-49a0-915d-5dd37a198c56