CTK OTC Laboratories LLC
FDA inspection history across 2 sites, 2024 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–25One Form 483 and one warning letter, at CORONA, California and Corona, California.
Cited most
Across all CTK OTC Laboratories observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194(a)(2)Laboratory records1
- 21 CFR 211.63Equipment design, size, and location1
The complete CTK OTC Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Corona, California
One warning letter · 2025
Latest: Warning letter, May 19, 2025 →CORONA, California
One Form 483 · 2024 · 4 observations
Latest: Form 483, Dec 31, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-19 | Warning letter Warning letter | Corona, California | — | $99 |
| 2024-12-31 | 483 Form 483 | CORONA, California | 4 | $99 |
Investigators on these documents
FEI number 3014253278 · most recent document May 19, 2025
About CTK OTC Laboratories LLC
How many FDA Form 483s has CTK OTC Laboratories LLC received?
FDA Intel has 1 Form 483 on file for CTK OTC Laboratories LLC; the most recent is dated Dec 31, 2024.
When was CTK OTC Laboratories LLC last inspected by FDA?
The most recent FDA inspection document on file for CTK OTC Laboratories LLC is a Form 483 dated Dec 31, 2024, for the site in CORONA, California.
What did FDA cite at CTK OTC Laboratories LLC?
The regulations cited most in the observations on file for CTK OTC Laboratories LLC are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194(a)(2) (Laboratory records), 1 time.
Has CTK OTC Laboratories LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CTK OTC Laboratories LLC; the most recent is dated May 19, 2025.