Atlas

Form 483

SEI Pharmaceuticals, Inc. Form 483, 2013-02-06

FDA issued a Form 483 to SEI Pharmaceuticals, Inc. on 2013-02-06 with 21 public-safe observations.

483· Form 483 issued21 observations

SEI Pharmaceuticals, Inc. · Miami, United States · Issued February 6, 2013

Overview

  • 21 public-safe observations are available for this inspection.
  • 19 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

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

Inspected site

SPSEI Pharmaceuticals, Inc.Miami, United States

Inspection team

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 111.103Cited 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 111.16Cited 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(b)Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 111.353Cited across public-safe Form 483 observations1x
21 CFR 111.430(b)Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited 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 111.75(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
21 CFR 111.8Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 21 observations

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