Company
United StatesCrown Laboratories Inc, Johnson City, TN – FDA Inspections
Inspection records and compliance data for Crown Laboratories Inc in Johnson City, Tennessee. 8 FDA inspections on record (2 OAI), 1 Form 483, last inspected September 19, 2025.
Company Profile
This profile covers Crown Laboratories Inc based in Johnson City, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 2
- VAI
- 4
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 3, 2011. Last inspected September 19, 2025.
Most cited issue areas
- Control procedures fail to include the following2 inspections
- Control procedures to monitor and validate performance2 inspections
- Procedures not in writing, fully followed2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1254956 |
| March 15, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1050586 |
| February 15, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1045454 |
| April 8, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 973822 |
| September 24, 2014 | OAI | Human Drugs · Unapproved and Misbranded Drugs | 898298 |
| February 14, 2014 | OAI | Human Drugs · Unapproved and Misbranded Drugs | 866595 |
| March 9, 2012 | VAI | Human Drugs · Drug Quality Assurance | 772058 |
| November 3, 2011 | VAI | Human Drugs · Drug Quality Assurance | 752766 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Crown Laboratories Inc
FEI Number
1019820
Address
349 Lafe Cox Dr, Johnson City, Tennessee 37604, United States
Country
United States
ID: abf83f84-3545-4b6e-95fc-8294fb9e1333