Form 483

Dr. J Skinclinic, Inc Form 483, 2026-03-23

FDA issued a Form 483 to Dr. J Skinclinic, Inc on 2026-03-23 with 7 public-safe observations.

483· Form 483 issuedHuman Drugs7 observations

Dr. J Skinclinic, Inc · Cerritos, United States · Issued March 23, 2026

Overview

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

Inspectional observations

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

23 Mar 2026
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Navneet Kaur, Devisree P Mattigiri, Joshua S Lee

23 Mar 2026
21 CFR 211.165(e)

Test methods

Cited by Navneet Kaur, Devisree P Mattigiri, Joshua S Lee

23 Mar 2026
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Navneet Kaur, Devisree P Mattigiri, Joshua S Lee

23 Mar 2026
21 CFR 211.180(e)

Records reviewed annually

Cited by Navneet Kaur, Devisree P Mattigiri, Joshua S Lee

23 Mar 2026
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Navneet Kaur, Devisree P Mattigiri, Joshua S Lee

Inspected site

DJDr. J Skinclinic, IncCerritos, United States

Inspection team

DPDevisree P Mattigiri
JSJoshua S Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 observations

The full inspection record, as Atlas holds it, 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