Site records / Maharashtra / FEI 3007005296

Aarti Pharmalabs LimitedThane, Maharashtra

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

Inspections posted: None
Last inspection: None posted
Warning letters to this FEI: 0
Import alerts at this address: 0
US border refusals, 2 years: 0

The site dossier

The full record.
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%.

FDA has posted no classified inspection for this site, so its dossier carries no grade. It holds the rest of the record: registration, import alerts, border refusals and the company's other sites.

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Inspections

FDA has posted no inspection of this FEI. That is an absence of record, not a clean one.

Warning letters and compliance actions

No FDA compliance action recorded against this FEI or letter to its name.

Import alerts in force

No listing in force under this firm's name.

Registration

FEI: 3007005296
DUNS: 650459014
Registered as: AARTI PHARMALABS LIMITED
Registrant: AARTI PHARMALABS LIMITED
Address: Plot No. D - 53, 55, 56, 57, 59 & 60, M.I.D.C. Phase-II, Kalyan-Shil Road, Dombivli (East), Thane, Maharashtra 421204, India (IND)
Operations: API 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.