Form 483

Dr. J Skinclinic, Inc Form 483, 2022-03-17

FDA issued a Form 483 to Dr. J Skinclinic, Inc on 2022-03-17 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Dr. J Skinclinic, Inc · Cerritos, United States · Issued March 17, 2022

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.

17 Mar 2022
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Wenzheng Zhang, Hung H Do

17 Mar 2022
21 CFR 211.180(c)

Records not made readily available to FDA

Cited by Wenzheng Zhang, Hung H Do

17 Mar 2022
21 CFR 211.180(e)

Records reviewed annually

Cited by Wenzheng Zhang, Hung H Do

17 Mar 2022
21 CFR 211.84(d)(1)

Component identity verification

Cited by Wenzheng Zhang, Hung H Do

Inspected site

DJDr. J Skinclinic, IncCerritos, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(c)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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