CTK OTC Laboratories LLC
Form 483 issued December 31, 2024 · CORONA, California
- Inspection
- Dec 16 – Dec 31, 2024
- Investigator
- Pearl C. Ozuruigbo
- Observations
- 4
- Pages
- 7
- FEI number
- 3014253278
In short: On December 31, 2024, FDA issued a Form 483 with 4 observations to CTK OTC Laboratories LLC in CORONA, California (FEI 3014253278) after an inspection that ran Dec 16 – Dec 31, 2024. The investigator was Pearl C. Ozuruigbo. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of…
- 02
Written procedures are not established and followed that describe the in-process controls to be conducted on…
- 03
The suitability of all testing methods is not verified under…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Pearl C. Ozuruigbo
6 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCTK OTC Laboratories LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CTK OTC Laboratories LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected CTK OTC Laboratories LLC?
Pearl C. Ozuruigbo is named on this Form 483, for the inspection of Dec 16 – Dec 31, 2024. Each investigator has a profile showing what they cite most.
When was CTK OTC Laboratories LLC inspected by FDA?
The inspection ran Dec 16 – Dec 31, 2024, and the Form 483 is dated December 31, 2024.
How do I get the full Form 483 for CTK OTC Laboratories LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.