Company
United StatesGram Laboratories Inc, Irvine, CA – FDA Inspections
Inspection records and compliance data for Gram Laboratories Inc in Irvine, California. 6 FDA inspections on record, 1 Form 483, last inspected April 08, 2025.
Company Profile
This profile covers Gram Laboratories Inc based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected February 16, 2010. Last inspected April 8, 2025.
Most cited issue areas
- Equipment Design, Size and Location1 inspection
- GMP Training Frequency1 inspection
- Written record of investigation incomplete1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 8, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1269575 |
| September 19, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1068237 |
| September 4, 2015 | VAI | Human Drugs · Drug Quality Assurance | 941212 |
| October 30, 2012 | NAI | Human Drugs · Drug Quality Assurance | 805255 |
| July 13, 2011 | NAI | Human Drugs · Drug Quality Assurance | 733887 |
| February 16, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645522 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gram Laboratories Inc
FEI Number
3002657995
Address
1761 Kaiser Ave, Irvine, California 92614, United States
Country
United States
ID: f54a2075-d931-4c44-a97c-e63f05375d9a