Atlas

Form 483

C.J. Labs, Inc. Form 483, 2011-06-24

FDA issued a Form 483 to C.J. Labs, Inc. on 2011-06-24 with 18 public-safe observations.

483· Form 483 issued18 observations

C.J. Labs, Inc. · Miami, United States · Issued June 24, 2011

Overview

  • 18 public-safe observations are available for this inspection.
  • 16 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.

24 Jun 2011
21 CFR 111.12

Personnel - quality control personnel - qualified

Cited by Rachel Peters

24 Jun 2011
21 CFR 111.14(b)(1)

Personnel - records - written procedures

Cited by Rachel Peters

24 Jun 2011
21 CFR 111.15(k)

Sanitation supervisors - assigned

Cited by Rachel Peters

24 Jun 2011
21 CFR 111.20(f)

Physical plant - bulbs, fixtures, skylights

Cited by Rachel Peters

24 Jun 2011
21 CFR 111.23(b)

Records - cleaning, pest control

Cited by Rachel Peters

Inspected site

CLC.J. Labs, 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 111.105Cited across public-safe Form 483 observations1x
21 CFR 111.12Cited across public-safe Form 483 observations1x
21 CFR 111.14(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.15(k)Cited across public-safe Form 483 observations1x
21 CFR 111.20(f)Cited across public-safe Form 483 observations1x
21 CFR 111.205(c)Cited across public-safe Form 483 observations1x
21 CFR 111.23(b)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(1)(iii)Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 111.475(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 111.83(b)(4)Cited 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 18 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