Atlas

Form 483

ENERGON LABS PRIVATE LIMITED Form 483, 2023-01-13

FDA issued a Form 483 to ENERGON LABS PRIVATE LIMITED on 2023-01-13 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

ENERGON LABS PRIVATE LIMITED · Hyderabad, India · Issued January 13, 2023

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.

13 Jan 2023
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Saied A Asbagh

13 Jan 2023
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Saied A Asbagh

Inspected site

ELENERGON LABS PRIVATE LIMITEDHyderabad, India

Inspection team

SASaied A Asbagh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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