Atlas

Form 483

Otsuka Pharmaceutical Co., Ltd. Form 483, 2014-03-20

FDA issued a Form 483 to Otsuka Pharmaceutical Co., Ltd. on 2014-03-20 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Otsuka Pharmaceutical Co., Ltd. · Itano-Gun, Japan · Issued March 20, 2014

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

20 Mar 2014
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Vlada Matusovsky, Sina Shojaee

20 Mar 2014
21 CFR 211.86

Rotation of components/containers/closures

Cited by Vlada Matusovsky, Sina Shojaee

20 Mar 2014
21 CFR 211.160(b)(4)

Establishment of calibration procedures

Cited by Vlada Matusovsky, Sina Shojaee

20 Mar 2014
21 CFR 211.192

Written record of investigation incomplete

Cited by Vlada Matusovsky, Sina Shojaee

Inspected site

OPOtsuka Pharmaceutical Co., Ltd.Itano-Gun, Japan

Inspection team

VMVlada Matusovsky
SSSina Shojaee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.86Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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