Atlas

Form 483

Doctors' Analytical Laboratories Private Limited Form 483, 2017-11-02

FDA issued a Form 483 to Doctors' Analytical Laboratories Private Limited on 2017-11-02 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

Doctors' Analytical Laboratories Private Limited · Navi Mumbai, India · Issued November 2, 2017

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

2 Nov 2017
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Saleem A Akhtar

2 Nov 2017
21 CFR 211.165(e)

Test methods

Cited by Saleem A Akhtar

2 Nov 2017
21 CFR 211.194(a)(2)

Test methods ID and data location

Cited by Saleem A Akhtar

2 Nov 2017
21 CFR 211.63

Equipment Design, Size and Location

Cited by Saleem A Akhtar

2 Nov 2017
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Saleem A Akhtar

Inspected site

DADoctors' Analytical Laboratories Private LimitedNavi Mumbai, India

Inspection team

SASaleem A Akhtar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(e)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

The full inspection record, as Atlas holds it, 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