Site records / Andhra Pradesh / FEI 3004611182

Apitoria Pharma Private LimitedSrikakulam, Andhra Pradesh

FDA-registered drug establishment in Srikakulam, Andhra Pradesh: analysis, api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
6
Last inspection
Aug 2022 · 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

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

  1. 2 Aug 2022VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 9 Feb 2019OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  3. 21 Feb 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 30 Apr 2015NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  5. 8 Jun 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 22 Oct 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 20 Jun 2019Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

  1. 2 Aug 2022Form 483 · 3 pages Source

Other registered sites of Apitoria Pharma Private Limited

Registration

FEI
3004611182
DUNS
918917626
Registered as
Apitoria Pharma Private Limited
Registrant
Apitoria Pharma Private Limited
Address
Unit-IV, Sy.No's.52,53,58,59,61 to 78,127&128, Pydibhimavaram V & Sy.No 1,2,4to9,11,29,30,31&32, Chittivalasa V, Ranasthalam Mandal, Srikakulam, Andhra Pradesh 532409, India (IND)
Operations
ANALYSIS, API MANUFACTURE
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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