Atlas

FDA-Inspected Site

SEI Pharmaceuticals, Inc.

4 FDA inspections are on record for SEI Pharmaceuticals, Inc. in Miami, United States.

483· Form 483 issued

Miami, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2013-02-06.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Feb 2013Not recorded483View 483 →
29 Sep 2011Not recordedWLView 483 →
13 May 2008Not recordedClean
1 May 2008Not recordedClean

Observations on record

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

6 Feb 2013
21 CFR 111.8

Written procedures - personnel qualifications

Cited by Rachel Peters

6 Feb 2013
21 CFR 111.12(c)

Personnel - education, training, experience

Cited by Rachel Peters

6 Feb 2013
21 CFR 111.15(d)(2)

Pest control measures

Cited by Rachel Peters

6 Feb 2013
21 CFR 111.16

Written procedures - cleaning

Cited by Rachel Peters

6 Feb 2013
21 CFR 111.25

Equipment - procedures

Cited by Rachel Peters

Investigators

FDA investigators tied to this site in the record.

Rachel Peters2 insp.
Joanne E King2 insp.
Edwin J Gorney2 insp.
German Rivera1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.153Cited across public-safe Form 483 observations4x
21 CFR 111.403Cited across public-safe Form 483 observations4x
21 CFR 111.103Cited across public-safe Form 483 observations2x
21 CFR 111.12(c)Cited across public-safe Form 483 observations2x
21 CFR 111.15(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.16Cited across public-safe Form 483 observations2x
21 CFR 111.205(a)Cited across public-safe Form 483 observations2x
21 CFR 111.25Cited across public-safe Form 483 observations2x
21 CFR 111.353Cited across public-safe Form 483 observations2x
21 CFR 111.453Cited across public-safe Form 483 observations2x
21 CFR 111.553Cited across public-safe Form 483 observations2x
21 CFR 111.605Cited across public-safe Form 483 observations2x
21 CFR 111.8Cited across public-safe Form 483 observations2x
21 CFR 111.10(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 111.12(b)Cited across public-safe Form 483 observations1x
21 CFR 111.15(f)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.15(k)Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.27(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.303Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 111.430(b)Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind SEI Pharmaceuticals, Inc.'s 2 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