Site records / Telangana / FEI 3004544153

Sipra Labs LimitedHyderabad, Telangana

FDA-registered drug establishment in Hyderabad, Telangana: analysis. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
4
Last inspection
Sep 2024 · VAI
Warning letters to this FEI
1
Import alerts at this address
0
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

4 FDA inspections of this FEI, by end date; 4 with a posted classification.

  1. 27 Sep 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 1 Mar 2014OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  3. 22 Sep 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 17 Apr 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 23 Jul 2015Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Registration

FEI
3004544153
DUNS
916701498
Registered as
SIPRA LABS LIMITED
Registrant
Sipra Labs Limited
Address
H. No. 7-2-1813/5/A, Sy. No. 59/6, Sanath Nagar, Adjacent to Post Office, Industrial Estate, Hyderabad, Telangana 500018, India (IND)
Operations
ANALYSIS
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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