Form 483

Ningbo Pulisi Daily Chemical Products Co., Ltd Form 483, 2014-03-21

FDA issued a Form 483 to Ningbo Pulisi Daily Chemical Products Co., Ltd on 2014-03-21 with 10 public-safe observations.

483· Form 483 issuedHuman Drugs10 observations

Ningbo Pulisi Daily Chemical Products Co., Ltd · Yuyao City, China · Issued March 21, 2014

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

21 Mar 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jose E Melendez

21 Mar 2014
21 CFR 211.67(b)(6)

Cleaning SOP/inspection

Cited by Jose E Melendez

21 Mar 2014
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Jose E Melendez

21 Mar 2014
21 CFR 211.82(a)

Examination on receipt, before acceptance

Cited by Jose E Melendez

21 Mar 2014
21 CFR 211.84(b)

Representative Samples Criteria

Cited by Jose E Melendez

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.122(e)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.82(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 observations

Every observation in full, 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