Company
Dominican Republic (the)Laboratorios Dr. Collado S.A., Santo Domingo Norte, Dominican Republic (the) – FDA Inspections
Inspection records and compliance data for Laboratorios Dr. Collado S.A. in Santo Domingo Norte. 3 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected April 21, 2023.
Company Profile
This profile covers Laboratorios Dr. Collado S.A. based in Santo Domingo Norte, Dominican Republic (the).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected November 21, 2014. Last inspected April 21, 2023.
Most cited issue areas
- Backup data not assured as exact and complete1 inspection
- GMP Training Frequency1 inspection
- Inadequate number of personnel1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1204028 |
| June 24, 2016 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 989332 |
| November 21, 2014 | VAI | Human Drugs · Drug Quality Assurance | 909160 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Laboratorios Dr. Collado S.A.
FEI Number
3000989764
Address
Parque Industrial Duarte Km 22 1/2, Autopista Duarte, Santo Domingo Norte, Dominican Republic (the)
Country
Dominican Republic (the)
ID: 33548ed1-1d0e-4cf9-a9fd-7ce36d847839