Company
United StatesKeystone Laboratories, Inc., Memphis, TN – FDA Inspections
Inspection records and compliance data for Keystone Laboratories, Inc. in Memphis, Tennessee. 8 FDA inspections on record (5 OAI), 1 Form 483, last inspected November 16, 2017.
Company Profile
This profile covers Keystone Laboratories, Inc. based in Memphis, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 5
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected July 1, 2009. Last inspected November 16, 2017.
Most cited issue areas
- Valid stability test methods4 inspections
- Absence of Written Procedures3 inspections
- Buildings not maintained in good state of repair3 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 16, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1038087 |
| February 5, 2016 | OAI | Human Drugs · Drug Quality Assurance | 984429 |
| March 13, 2015 | VAI | Human Drugs · Drug Quality Assurance | 917925 |
| September 12, 2014 | OAI | Human Drugs · Drug Quality Assurance | 897322 |
| August 15, 2013 | OAI | Human Drugs · Drug Quality Assurance | 846286 |
| August 29, 2012 | OAI | Human Drugs · Drug Quality Assurance | 798912 |
| June 10, 2011 | VAI | Human Drugs · Drug Quality Assurance | 730608 |
| July 1, 2009 | VAI | Foods & Cosmetics, Human Drugs · Colors and Cosmetics Technology | 597192 |
FDA documents
Form 483s (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Keystone Laboratories, Inc.
FEI Number
1020139
Address
1103 Kansas St, Memphis, Tennessee 38106, United States
Country
United States
ID: 5e1c645f-1f15-4149-8ce3-f73d0b0eb564