Ca-Botana International
Form 483 issued April 4, 2025 · SAN DIEGO, California
- Inspection
- Apr 2 – Apr 4, 2025
- Investigator
- Cecilia H. Kieu
- Observations
- 5
- Pages
- 5
- FEI number
- 2023910
In short: On April 4, 2025, FDA issued a Form 483 with 5 observations to Ca-Botana International in SAN DIEGO, California (FEI 2023910) after an inspection that ran Apr 2 – Apr 4, 2025. The investigator was Cecilia H. Kieu. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Drug products failing to meet established standards and…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmCa-Botana International history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ca-Botana International?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ca-Botana International?
Cecilia H. Kieu is named on this Form 483, for the inspection of Apr 2 – Apr 4, 2025. Each investigator has a profile showing what they cite most.
When was Ca-Botana International inspected by FDA?
The inspection ran Apr 2 – Apr 4, 2025, and the Form 483 is dated April 4, 2025.
How do I get the full Form 483 for Ca-Botana International?
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.