Atlas

FDA-Inspected Site

AIAC International Pharma, LLC

4 FDA inspections are on record for AIAC International Pharma, LLC in Arecibo, United States.

483· Form 483 issued

Arecibo, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-07.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Nov 2025 – 7 Nov 2025Human Drugs483View 483 →
16 Mar 2021 – 23 Mar 2021Human DrugsClean
22 May 2018 – 1 Jun 2018Human Drugs483View 483 →
10 Aug 2015 – 17 Aug 2015Human Drugs483View 483 →

Observations on record

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

7 Nov 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Marian E Ramirez, Yoriann M Cabrera Bartolomei

1 Jun 2018
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Marian E Ramirez

17 Aug 2015
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Noreen Muniz, Charanjeet Jassal

17 Aug 2015
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Noreen Muniz, Charanjeet Jassal

17 Aug 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Noreen Muniz, Charanjeet Jassal

Investigators

FDA investigators tied to this site in the record.

Marian E Ramirez3 insp.
Yoriann M Cabrera Bartolomei1 insp.
Noreen Muniz1 insp.
Charanjeet Jassal1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind AIAC International Pharma, LLC's 3 Form 483s

Source PDFs, verbatim observations, 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