Hikal Limited
Form 483 issued August 2, 2019 · Bengaluru, India
- Investigator
- Maria E. Estrella
- Observations
- 1
- Pages
- 1
- FEI number
- 3003560263
In short: On August 2, 2019, FDA issued a Form 483 with 1 observation to Hikal Limited in Bengaluru, Karnataka (FEI 3003560263). The investigator was Maria E. Estrella. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your laboratory procedures are not fully followed, and records are not completed at…
This inspection in context
Maria E. Estrella
6 documents · 2017–2026
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in India.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikal Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Hikal Limited?
Maria E. Estrella is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hikal Limited inspected by FDA?
This Form 483 is dated August 2, 2019.
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.