Company
CanadaIsomers Laboratories Inc., North York, Canada – FDA Inspections
Inspection records and compliance data for Isomers Laboratories Inc. in North York. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 25, 2019.
Company Profile
This profile covers Isomers Laboratories Inc. based in North York, Canada.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 29, 2011. Last inspected September 25, 2019.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Actual vs. theoretical yields not determined1 inspection
- Annual visual exams of drug products1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2019 | Not classified | Human Drugs · Unapproved and Misbranded Drugs | 1102733 |
| May 11, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1054191 |
| May 29, 2014 | VAI | Human Drugs · Drug Quality Assurance | 884454 |
| September 29, 2011 | VAI | Human Drugs · Drug Quality Assurance | 752282 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Isomers Laboratories Inc.
FEI Number
3001576415
Address
105 Tycos Dr, North York, Canada
Country
Canada
ID: 98728abb-b61b-4907-95b5-9b3d130f89c2