Ca-Botana International
Form 483 issued November 12, 2019 · SAN DIEGO, California
- Inspection
- Nov 5 – Nov 12, 2019
- Observations
- 7
- Pages
- 6
- FEI number
- 2023910
In short: On November 12, 2019, FDA issued a Form 483 with 7 observations to Ca-Botana International in SAN DIEGO, California (FEI 2023910) after an inspection that ran Nov 5 – Nov 12, 2019. Most observations concern laboratory controls and materials.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Questions about this 483
What did FDA find at Ca-Botana International?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, materials and quality system. The opening words of each observation are shown on this page.
When was Ca-Botana International inspected by FDA?
The inspection ran Nov 5 – Nov 12, 2019, and the Form 483 is dated November 12, 2019.
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.