Form 483

Dsquared Pharmaceuticals, Inc. Form 483, 2018-02-13

FDA issued a Form 483 to Dsquared Pharmaceuticals, Inc. on 2018-02-13 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

Dsquared Pharmaceuticals, Inc. · Phoenix, United States · Issued February 13, 2018

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

13 Feb 2018
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Gloria J Baca

13 Feb 2018
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Gloria J Baca

13 Feb 2018
21 CFR 211.180(e)(2)

Items to cover on annual reviews

Cited by Gloria J Baca

13 Feb 2018
21 CFR 211.22(a)

Lack of quality control unit

Cited by Gloria J Baca

13 Feb 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Gloria J Baca

Inspected site

DPDsquared Pharmaceuticals, Inc.Phoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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