Harman Finochem Limited
Form 483 issued March 22, 2024 · Chhatrapati Sambhajinagar, India
- Inspection
- Mar 18 – Mar 22, 2024
- Investigator
- Lisa L. Flores
- Observations
- 1
- Pages
- 1
- FEI number
- 3003130103
In short: On March 22, 2024, FDA issued a Form 483 with 1 observation to Harman Finochem Limited in Chhatrapati Sambhajinagar, Maharashtra (FEI 3003130103) after an inspection that ran Mar 18 – Mar 22, 2024. The investigator was Lisa L. Flores. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmHarman Finochem Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Harman Finochem Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Harman Finochem Limited?
Lisa L. Flores is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2024. Each investigator has a profile showing what they cite most.
When was Harman Finochem Limited inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2024, and the Form 483 is dated March 22, 2024.
How do I get the full Form 483 for Harman Finochem 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.