Site records / Daman / FEI 3006370524

Alkem Laboratories LimitedVillage Dabhel, Daman

FDA-registered drug establishment in Village Dabhel, Daman: analysis, manufacture, pack, repack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted: 6
Last inspection: Aug 2019 · NAI
Warning letters to this FEI: 0
Import alerts at this address: 0
US border refusals, 2 years: 1

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

6 FDA inspections of this FEI, by end date; 6 with a posted classification.

30 Aug 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
18 Jan 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
27 Mar 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 13 citations posted
29 Sep 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
25 Oct 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
9 Dec 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

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.

Form 483s released by FDA

29 Sep 2016Form 483 · 11 pages Source
27 Mar 2018Form 483 · 16 pages Source
1 May 2026Form 483 · 26 pages Source

Other registered sites of Alkem Laboratories

Alkem Laboratories LimitedBaddi, Himachal Pradesh
Alkem Laboratories LimitedBharuch, Gujarat
Alkem Laboratories LimitedBharuch, Gujarat

Registration

FEI: 3006370524
DUNS: 915628612
Registered as: Alkem Laboratories Limited
Registrant: Alkem Laboratories Limited
Address: Srv. No. 167, Plot No. 164, 165/1, 165/2, 165/3, 168/215, 168/216, 168/234, Village Dabhel, Daman, Dadra & Nagar Haveli and Daman & Diu 396210, India (IND)
Operations: ANALYSIS, MANUFACTURE, PACK, REPACK
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.