Form 483

260 Commercial Investments Inc. Form 483, 2012-07-30

FDA issued a Form 483 to 260 Commercial Investments Inc. on 2012-07-30 with 6 public-safe observations.

483· Form 483 issued6 observations

260 Commercial Investments Inc. · Portland, United States · Issued July 30, 2012

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

30 Jul 2012
21 CFR 123.6(c)(3)

Critical limits

Cited by Rupa Pradhan

30 Jul 2012
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Rupa Pradhan

30 Jul 2012
21 CFR 123.7(d)

Corrective action documentation

Cited by Rupa Pradhan

30 Jul 2012
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Rupa Pradhan

30 Jul 2012
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Rupa Pradhan

Inspected site

2C260 Commercial Investments Inc.Portland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.7(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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