Company
United StatesLaboratorio Analitico, Inc., Coto Laurel, PR – FDA Inspections
Inspection records and compliance data for Laboratorio Analitico, Inc. in Coto Laurel, Puerto Rico. 5 FDA inspections on record, 1 Form 483, last inspected February 14, 2018.
Company Profile
This profile covers Laboratorio Analitico, Inc. based in Coto Laurel, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 7, 2011. Last inspected February 14, 2018.
Most cited issue areas
- Instruments, apparatus, et. al. not meeting specs2 inspections
- Establishment of calibration procedures1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1043876 |
| June 10, 2015 | NAI | Human Drugs · Drug Quality Assurance | 929533 |
| March 11, 2013 | NAI | Human Drugs · Drug Quality Assurance | 821729 |
| December 19, 2011 | VAI | Human Drugs · Drug Quality Assurance | 759487 |
| February 7, 2011 | VAI | Human Drugs · Drug Quality Assurance | 708769 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Laboratorio Analitico, Inc.
FEI Number
2649843
Address
1720 Carr 506 Ste 205, Coto Laurel, Puerto Rico 00780, United States
Country
United States
ID: 31dd63f4-72d5-4dd2-9f90-2b933803ff8a