Atlas

Form 483

Dynamic Pharmaceuticals, Inc. Form 483, 2013-07-19

FDA issued a Form 483 to Dynamic Pharmaceuticals, Inc. on 2013-07-19 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Dynamic Pharmaceuticals, Inc. · Brooksville, United States · Issued July 19, 2013

Overview

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

Inspectional observations

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

19 Jul 2013
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Melanie W Pishnery, Mizanne E Lewis

19 Jul 2013
21 CFR 111.205(b)(1)

Master manufacturing record - specifications; quality

Cited by Melanie W Pishnery, Mizanne E Lewis

19 Jul 2013
21 CFR 111.210(h)(2)

Master manufacturing record - sampling, tests, examinations

Cited by Melanie W Pishnery, Mizanne E Lewis

Inspected site

DPDynamic Pharmaceuticals, Inc.Brooksville, United States

Inspection team

MWMelanie W Pishnery
MEMizanne E Lewis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.205(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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