Form 483

N-Molecular, Inc. dba SOFIE Form 483, 2015-08-07

FDA issued a Form 483 to N-Molecular, Inc. dba SOFIE on 2015-08-07 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

N-Molecular, Inc. dba SOFIE · Haverhill, United States · Issued August 7, 2015

Overview

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

Inspectional observations

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

7 Aug 2015
21 CFR 212.30(b)

Equipment not clean

Cited by Chad N Thompson

7 Aug 2015
21 CFR 212.30(b)

Equipment not clean

Cited by Chad N Thompson

Inspected site

NIN-Molecular, Inc. dba SOFIEHaverhill, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.30(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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