Atlas

Form 483

Blossom Pharmaceuticals Form 483, 2016-12-16

FDA issued a Form 483 to Blossom Pharmaceuticals on 2016-12-16 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Blossom Pharmaceuticals · Bardej, Goa, India · Issued December 16, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Dec 2016
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Charanjeet Jassal

16 Dec 2016
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Charanjeet Jassal

16 Dec 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Charanjeet Jassal

Inspected site

BPBlossom PharmaceuticalsBardej, Goa, India

Inspection team

CJCharanjeet Jassal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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