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Form 483

YUNG SHIN PHARM. IND. CO., LTD. Form 483, 2019-09-12

FDA issued a Form 483 to YUNG SHIN PHARM. IND. CO., LTD. on 2019-09-12 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

YUNG SHIN PHARM. IND. CO., LTD. · Taichung City, Taiwan · Issued September 12, 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.

12 Sep 2019
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Samina S Khan

12 Sep 2019
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Samina S Khan

Inspected site

YSYUNG SHIN PHARM. IND. CO., LTD.Taichung City, Taiwan

Inspection team

SSSamina S Khan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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