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Form 483

N-Molecular, Inc. dba SOFIE Form 483, 2019-05-16

FDA issued a Form 483 to N-Molecular, Inc. dba SOFIE on 2019-05-16 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

N-Molecular, Inc. dba SOFIE · Haverhill, United States · Issued May 16, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

16 May 2019
21 CFR 212.20(e)

Written QA procedures established, followed

Cited by Sean R Marcsisin

16 May 2019
21 CFR 212.60(e)

Equipment

Cited by Sean R Marcsisin

Inspected site

NIN-Molecular, Inc. dba SOFIEHaverhill, United States

Inspection team

SRSean R Marcsisin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.20(e)Cited across public-safe Form 483 observations1x
21 CFR 212.60(e)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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