Company
United StatesShalem Products Inc, Angora, MN – FDA Inspections
Inspection records and compliance data for Shalem Products Inc in Angora, Minnesota. 5 FDA inspections on record, 1 Form 483, last inspected September 24, 2019.
Company Profile
This profile covers Shalem Products Inc based in Angora, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected August 18, 2009. Last inspected September 24, 2019.
Most cited issue areas
- Scientifically sound laboratory controls1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 24, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1103066 |
| June 30, 2014 | NAI | Human Drugs · Drug Quality Assurance | 888478 |
| July 24, 2013 | NAI | Human Drugs · Drug Quality Assurance | 847508 |
| February 21, 2010 | NAI | Human Drugs · Drug Quality Assurance | 652445 |
| August 18, 2009 | NAI | Human Drugs · Drug Quality Assurance | 610952 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Shalem Products Inc
FEI Number
1000139793
Address
9315 E Goodell Rd, Angora, Minnesota 55703, United States
Country
United States
ID: 424685ae-ae46-4ce9-aaa0-19a5799df5f7