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Form 483

Daito Pharmaceutical Co., Ltd Form 483, 2023-12-19

FDA issued a Form 483 to Daito Pharmaceutical Co., Ltd on 2023-12-19 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Daito Pharmaceutical Co., Ltd · Toyama, Japan · Issued December 19, 2023

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.

19 Dec 2023
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Truong X Nguyen

19 Dec 2023
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Truong X Nguyen

Inspected site

DPDaito Pharmaceutical Co., LtdToyama, Japan

Inspection team

TXTruong X Nguyen

Cited regulations

CFR citations associated with this Form 483.

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