Site records / Tamil Nadu / FEI 3008386908
Gland Chemicals Private LimitedKanchipuram, Tamil Nadu
FDA-registered drug establishment in Kanchipuram, Tamil Nadu: analysis, label, manufacture, pack, sterilize. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 6
- Last inspection
- Nov 2025 · OAI
- Warning letters to this FEI
- 2
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 0
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.
- 27 Nov 2025OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 3 Apr 2018OAI · Official Action IndicatedDrug Quality Assurance · 11 citations posted
- 4 Feb 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · 7 citations posted
- 10 Dec 2013OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 10 Oct 2012OAI · Official Action IndicatedDrug Quality Assurance · 5 citations posted
- 30 Mar 2011NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 4 Mar 2019Warning Letter · CDER
- 28 May 2013Warning Letter · CDER
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 Aug 2018Import alert 66-40 · Published address is not this site SourcePublished address: & B - 11 Plot No B - 3 , Sipcot Industrial Park; & B - 6 To B - 18 , Chennai, Tamil Nadu INDIA
Form 483s released by FDA
Other registered sites of Gland Chemicals Private Limited
- Gland Chemicals Private LimitedMalur, Karnataka
- Gland Chemicals Private LimitedAurangabad, Maharashtra
Registration
- FEI
- 3008386908
- DUNS
- 914234285
- Registered as
- GLAND CHEMICALS PRIVATE LIMITED
- Registrant
- Gland Chemicals Private Limited
- Address
- Plot No. B-3, B-4,B-5 (Part) & B-6 (Part) & B-11 to B-18, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kanchipuram, Tamil Nadu 602117, India (IND)
- Operations
- ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE
- 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.