Hikal Limited
Form 483 issued February 7, 2025 · Jigani, Anekal, Bengaluru, India
- Inspection
- Feb 3 – Feb 7, 2025
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 6
- Pages
- 7
- FEI number
- 3003560263
In short: On February 7, 2025, FDA issued a Form 483 with 6 observations to Hikal Limited in Jigani, Anekal, Bengaluru, Anekal (FEI 3003560263) after an inspection that ran Feb 3 – Feb 7, 2025. The investigator was Marcellinus D. Dordunoo. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaints are not adequately investigated, and appropriate follow…
- 02
Out-Of-Specification (OOS) results are routinely invalidated, without sufficient supporting evidence or scientific justification…
- 03
Appropriate ~aintenance and calibration of critical…
- 04
Written procedures are…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmHikal Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikal Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Hikal Limited?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was Hikal Limited inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2025, and the Form 483 is dated February 7, 2025.
How do I get the full Form 483 for Hikal Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.