FDA-Inspected Site

CA BOTANA International, Inc.

8 FDA inspections are on record for CA BOTANA International, Inc. in San Diego, United States.

483· Form 483 issued

San Diego, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-04.

At a glance

Inspections

8

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Apr 2025 – 4 Apr 2025Human Drugs483View 483 →
5 Nov 2019 – 12 Nov 2019Human Drugs483View 483 →
5 Jan 2016 – 12 Jan 2016Human Drugs483On file
25 Feb 2013 – 1 Mar 2013Human Drugs483On file
25 Jul 2011Not recordedClean
25 Sep 2008Not recorded483On file
28 Aug 2008Not recorded483On file
30 Nov 2004Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

4 Apr 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Cecilia H Kieu

4 Apr 2025
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Cecilia H Kieu

4 Apr 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Cecilia H Kieu

4 Apr 2025
21 CFR 211.63

Equipment Design, Size and Location

Cited by Cecilia H Kieu

4 Apr 2025
21 CFR 211.84(d)(1)

Component identity verification

Cited by Cecilia H Kieu

Investigators

FDA investigators tied to this site in the record.

Linda Thai1 insp.
Ademola O Daramola1 insp.
Cntrctmntr Kelley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(f)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.150(b)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.89Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind CA BOTANA International, Inc.'s 6 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat