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Hikal — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Hikal (NSE: HIKAL, BSE: 524735), from US FDA records and exchange filings.
50
Compliance score (5 years) · how
2
USFDA-inspected plants on record
1
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified OAI — 07 Feb 2025 (Jigani plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2025
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Jigani Hikal Limited |
3003560263 | OAI | 07 Feb 2025 | |
| Panoli, Bharuch District Hikal Limited |
3009627283 | NAI | 12 May 2023 |
Full USFDA timeline
07 Feb 2025
OAI — serious issues
USFDA inspection classified OAI
Jigani · FEI 3003560263 · Hikal Limited, Jigani — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
12 May 2023
NAI — clean
USFDA inspection classified NAI
Panoli, Bharuch District · FEI 3009627283 · Hikal Limited, Panoli, Bharuch District — 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/hikal