Atlas

Form 483

Aquascience Technologies & Research, Inc Form 483, 2011-11-14

FDA issued a Form 483 to Aquascience Technologies & Research, Inc on 2011-11-14 with 2 public-safe observations.

483· Form 483 issued2 observations

Aquascience Technologies & Research, Inc · Richmond, United States · Issued November 14, 2011

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.

14 Nov 2011
21 CFR 211.165(a)

Testing and release for distribution

Cited by Victoria A Wagoner

14 Nov 2011
21 CFR 211.166(a)

Lack of written stability program

Cited by Victoria A Wagoner

Inspected site

ATAquascience Technologies & Research, IncRichmond, United States

Inspection team

VAVictoria A Wagoner

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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