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Form 483

Bushu Pharmaceuticals, Ltd. Form 483, 2022-12-02

FDA issued a Form 483 to Bushu Pharmaceuticals, Ltd. on 2022-12-02 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Bushu Pharmaceuticals, Ltd. · Kawagoe, Japan · Issued December 2, 2022

Overview

  • 6 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.

2 Dec 2022
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Noreen Muniz

2 Dec 2022
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Noreen Muniz

2 Dec 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Noreen Muniz

2 Dec 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Noreen Muniz

2 Dec 2022
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Noreen Muniz

Inspected site

BPBushu Pharmaceuticals, Ltd.Kawagoe, Japan

Inspection team

NMNoreen Muniz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 6 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