Form 483

Aquascience Technologies & Research, Inc Form 483, 2014-10-24

FDA issued a Form 483 to Aquascience Technologies & Research, Inc on 2014-10-24 with 5 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds5 observations

Aquascience Technologies & Research, Inc · Richmond, United States · Issued October 24, 2014

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

24 Oct 2014
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Ashley A Mutawakkil

24 Oct 2014
21 CFR 211.84(d)(1)

Identity Testing of Each Component

Cited by Ashley A Mutawakkil

24 Oct 2014
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Ashley A Mutawakkil

24 Oct 2014
21 CFR 211.165(a)

Testing and release for distribution

Cited by Ashley A Mutawakkil

24 Oct 2014
21 CFR 211.166(a)

Lack of written stability program

Cited by Ashley A Mutawakkil

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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