Site records / India / FEI 3008449456

Omni Lens Private LimitedAhmedabad

FDA-registered drug establishment in Ahmedabad: manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
1
Last inspection
Jul 2025 · VAI
Warning letters to this FEI
1
Import alerts at this address
1
US border refusals, 2 years
0
The site dossier

This site, graded.
Every fact sourced.

  • A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
  • Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
  • Warning-letter violations, numbered and labelled
  • Import-alert history rebuilt from the archive, each listing checked against this address
  • Border refusals by product, and the company's other sites, each graded
  • A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

1 FDA inspection of this FEI, by end date; 1 with a posted classification.

  1. 10 Jul 2025VAI · Voluntary Action IndicatedCompliance: Devices · no citations posted

Warning letters and compliance actions

  1. 2 Oct 2024Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

  1. 27 Sep 2024Import alert 66-40 · Published address is this site SourcePublished address: 5 Samrudddhi Ground Floor, Near Sattar Taluka Society, Navrangpura , Ahmedabad, Gujarat INDIA

Registration

FEI
3008449456
DUNS
862170057
Registered as
OMNI LENS PRIVATE LIMITED
Registrant
OMNI LENS PRIVATE LIMITED
Address
5 Samrudddhi Ground Floor, Near Sattar Taluka Society, Navrangpura, Ahmedabad, Gujrat 380014, India (IND)
Operations
MANUFACTURE
Registration expires
31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.

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