Atlas

Form 483

Sunshine Lake Pharma Co., Ltd. Form 483, 2019-01-25

FDA issued a Form 483 to Sunshine Lake Pharma Co., Ltd. on 2019-01-25 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Sunshine Lake Pharma Co., Ltd. · Dongguan, China · Issued January 25, 2019

Overview

  • 4 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.

25 Jan 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Roger F Zabinski

25 Jan 2019
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Roger F Zabinski

25 Jan 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Roger F Zabinski

25 Jan 2019
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Roger F Zabinski

Inspected site

SLSunshine Lake Pharma Co., Ltd.Dongguan, China

Inspection team

RFRoger F Zabinski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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