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Indoco Remedies — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Indoco Remedies (NSE: INDOCO, BSE: 532612), from US FDA records and exchange filings.

55
Compliance score (5 years) · how
4
USFDA-inspected plants on record
1
OAI classifications (5y)
1
Form 483s on record (5y)
1
Open warning letters
Latest USFDA record: USFDA inspection classified NAI — 19 Sep 2025 (Kaire plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2024
2025
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Kaire
Indoco Remedies Limited
 3006784730 NAI 19 Sep 2025
Navi Mumbai
Indoco Remedies Limited
 3006620783 NAI 16 May 2024
Verna
Indoco Remedies Limited
 3005124189 OAI 28 Feb 2023
Verna
Indoco Remedies Limited (Plant I)
 3006644152 VAI 20 Jan 2023

Full USFDA timeline

31 Oct 2025
US approval
USFDA tentative approval:
ANDA210312 —
Source: openFDA Drugs@FDA ↗
19 Sep 2025
NAI — clean
USFDA inspection classified NAI
Kaire · FEI 3006784730 · Indoco Remedies Limited, Kaire — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
16 Dec 2024
Warning letter
USFDA warning letter
Indoco Remedies Limited — CGMP/Finished Pharmaceuticals/Adulterated
Source: FDA warning letters ↗
05 Jun 2024
US approval
USFDA tentative approval:
ANDA210311 —
Source: openFDA Drugs@FDA ↗
16 May 2024
NAI — clean
USFDA inspection classified NAI
Navi Mumbai · FEI 3006620783 · Indoco Remedies Limited, Navi Mumbai — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
28 Feb 2023
OAI — serious issues
USFDA inspection classified OAI
Verna · FEI 3005124189 · Indoco Remedies Limited, Verna — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
20 Jan 2023
Form 483
Form 483: 1 observation
Verna · FEI 3006644152 · Procedures for non-sterile drug products
Source: FDA Data Dashboard (citations) ↗
20 Jan 2023
VAI — minor issues
USFDA inspection classified VAI
Verna · FEI 3006644152 · Indoco Remedies Limited (Plant I), Verna — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/indoco