Atlas

Form 483

Hetero Labs Limited Form 483, 2019-04-26

FDA issued a Form 483 to Hetero Labs Limited on 2019-04-26 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Hetero Labs Limited · Mahabubnagar, India · Issued April 26, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 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.

26 Apr 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lata C Mathew, Jogy George

26 Apr 2019
21 CFR 211.188(b)(10)

Documentation of Sampling Performed

Cited by Lata C Mathew, Jogy George

26 Apr 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lata C Mathew, Jogy George

Inspected site

HLHetero Labs LimitedMahabubnagar, India

Inspection team

LCLata C Mathew
JGJogy George

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(10)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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