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Form 483

SEI Pharmaceuticals, Inc. Form 483, 2011-09-29

FDA issued a Form 483 to SEI Pharmaceuticals, Inc. on 2011-09-29 with 25 public-safe observations.

483· Form 483 issued25 observations

SEI Pharmaceuticals, Inc. · Miami, United States · Issued September 29, 2011

Overview

  • 25 public-safe observations are available for this inspection.
  • 23 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

29 Sep 2011
21 CFR 111.8

Written procedures - personnel qualifications

Cited by German Rivera, Rachel Peters

29 Sep 2011
21 CFR 111.10(a)(2)

Personnel - health condition - supervisor notification

Cited by German Rivera, Rachel Peters

29 Sep 2011
21 CFR 111.10(b)(6)

Hair restraints

Cited by German Rivera, Rachel Peters

29 Sep 2011
21 CFR 111.12(b)

Personnel - quality control operations

Cited by German Rivera, Rachel Peters

29 Sep 2011
21 CFR 111.12(c)

Personnel - education, training, experience

Cited by German Rivera, Rachel Peters

Inspected site

SPSEI Pharmaceuticals, Inc.Miami, United States

Inspection team

GRGerman Rivera
RPRachel Peters

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.153Cited across public-safe Form 483 observations2x
21 CFR 111.403Cited 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 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.12(b)Cited across public-safe Form 483 observations1x
21 CFR 111.12(c)Cited across public-safe Form 483 observations1x
21 CFR 111.15(d)(2)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 111.16Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.25Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)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 111.353Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.605Cited across public-safe Form 483 observations1x
21 CFR 111.8Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 25 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere