Hikal Limited
FDA inspection history across 3 sites, 2019 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Bengaluru, India.
- 2025One warning letter and one Form 483, at Jigani, India and Jigani, Anekal, Bengaluru, India.
- 2025The longest 483 on file: 6 observations over 7 pages at Jigani, Anekal, Bengaluru, India.
Cited most
Across all Hikal Limited observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.198Complaint files1
The complete Hikal Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Jigani, India
One warning letter · 2025
Latest: Warning letter, Aug 20, 2025 →Jigani, Anekal, Bengaluru, India
One Form 483 · 2025 · 6 observations
Latest: Form 483, Feb 7, 2025 →Bengaluru, India
One Form 483 · 2019
Latest: Form 483, Aug 2, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-20 | Warning letter Warning letter | Jigani, India | — | $99 |
| 2025-02-07 | 483 Form 483 | Jigani, Anekal, Bengaluru, India | 6 | $99 |
| 2019-08-02 | 483 Form 483 | Bengaluru, India | — | $99 |
Investigators on these documents
FEI number 3003560263 · most recent document Aug 20, 2025
About Hikal Limited
How many FDA Form 483s has Hikal Limited received?
FDA Intel has 2 Form 483s on file for Hikal Limited; the most recent is dated Feb 7, 2025.
When was Hikal Limited last inspected by FDA?
The most recent FDA inspection document on file for Hikal Limited is a Form 483 dated Feb 7, 2025, for the site in Jigani, Anekal, Bengaluru, India.
What did FDA cite at Hikal Limited?
The regulations cited most in the observations on file for Hikal Limited are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Hikal Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hikal Limited; the most recent is dated Aug 20, 2025.