Site records / Himachal Pradesh / FEI 3006370533
Alkem Laboratories LimitedBaddi, Himachal Pradesh
FDA-registered drug establishment in Baddi, Himachal Pradesh: analysis, manufacture, pack, repack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 9
- Last inspection
- Mar 2024 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 5
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%.
PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.
By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.
Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan
Inspections
9 FDA inspections of this FEI, by end date; 9 with a posted classification.
- 27 Mar 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 21 Feb 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 26 Nov 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 17 May 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 4 citations posted
- 10 Mar 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 31 Jul 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 20 Sep 2013NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 31 Aug 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 6 Nov 2009VAI · 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
Other registered sites of Alkem Laboratories
- Alkem Laboratories LimitedVillage Dabhel, Daman
- Alkem Laboratories LimitedBharuch, Gujarat
- Alkem Laboratories LimitedBharuch, Gujarat
Registration
- FEI
- 3006370533
- DUNS
- 677605851
- Registered as
- Alkem Laboratories Limited
- Registrant
- Alkem Laboratories Limited
- Address
- Khasra No 1544, 1553, 1558, 1559 Village Thana, Tehsil Nalagarh, Baddi, Himachal Pradesh 173205, 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.