Site records / Telangana / FEI 3009876430
Shilpa Medicare LimitedMahabubnagar, Telangana
FDA-registered drug establishment in Mahabubnagar, Telangana: analysis, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 6
- Last inspection
- Feb 2020 · OAI
- Warning letters to this FEI
- 1
- Import alerts at this address
- 1
- 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.
- 25 Feb 2020OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 6 Sep 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
- 30 Nov 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 28 Jul 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 26 Jul 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 26 Aug 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 9 Oct 2020Warning 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.
- 16 Feb 2021Import alert 66-40 · Published address is this site SourcePublished address: Plot No. S20 to S26, Pharmaceutical Formulations SEZ , TSIIC Green Industrial Park, Polepally (Village) , Jadcherla, Mahabubnagar District , Telangana INDIA
Form 483s released by FDA
Other registered sites of Shilpa Medicare
- Shilpa Medicare LimitedBengaluru, Karnataka
- Shilpa Medicare LimitedBengaluru, Karnataka
- Shilpa Medicare LimitedHyderabad, Telangana
Registration
- FEI
- 3009876430
- DUNS
- 650644136
- Registered as
- SHILPA MEDICARE LIMITED
- Registrant
- SHILPA MEDICARE LIMITED
- Address
- S-20 to S-26, Pharmaceutical Formulations SEZ; TSIIC, Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, Telangana 509301, India (IND)
- Operations
- ANALYSIS, MANUFACTURE, PACK
- 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.