Company
United StatesCTK OTC Laboratories LLC, Corona, CA – FDA Inspections
Inspection records and compliance data for CTK OTC Laboratories LLC in Corona, California. 4 FDA inspections on record (1 OAI), 4 Form 483s, 1 warning letter, last inspected May 04, 2026.
Company Profile
This profile covers CTK OTC Laboratories LLC based in Corona, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 4
- Warning letters
- 1
First inspected October 22, 2018. Last inspected May 4, 2026.
Most cited issue areas
- Equipment Design, Size and Location3 inspections
- Written procedures not established/followed3 inspections
- Prepared for each batch, include complete information2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 4, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1316014 |
| December 31, 2024 | OAI | Human Drugs · Drug Quality Assurance | 1257783 |
| March 8, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1081833 |
| October 22, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1069380 |
FDA documents
Warning Letters (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CTK OTC Laboratories LLC
FEI Number
3014253278
Address
1690 N Delilah St, Corona, California 92879, United States
Country
United States
ID: b335f624-1732-48b8-9900-26989b236b51