Atlas

Form 483

CSPC Ouyi Pharmaceutical Co., Ltd. Form 483, 2018-06-15

FDA issued a Form 483 to CSPC Ouyi Pharmaceutical Co., Ltd. on 2018-06-15 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

CSPC Ouyi Pharmaceutical Co., Ltd. · Shijiazhuang, China · Issued June 15, 2018

Overview

  • 2 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.

15 Jun 2018
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Camerson E Moore

15 Jun 2018
21 CFR 211.67(b)

Written procedures fail to include

Cited by Camerson E Moore

Inspected site

COCSPC Ouyi Pharmaceutical Co., Ltd.Shijiazhuang, China

Inspection team

CECamerson E Moore

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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