Atlas

Form 483

Astral SteriTech Private Ltd. Form 483, 2015-05-11

FDA issued a Form 483 to Astral SteriTech Private Ltd. on 2015-05-11 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Astral SteriTech Private Ltd. · Vadodara, India · Issued May 11, 2015

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

11 May 2015
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Robert M Barbosa

11 May 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Robert M Barbosa

11 May 2015
21 CFR 211.167(a)

Sterility/pyrogens - test methods written, followed

Cited by Robert M Barbosa

Inspected site

ASAstral SteriTech Private Ltd.Vadodara, India

Inspection team

RMRobert M Barbosa

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)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