Unichem Laboratories Limited
Form 483 issued July 27, 2018 · Pithampur, India
- Inspection
- Jul 27, 2018
- Investigator
- William Leonard
- Observations
- 2
- Pages
- 2
In short: On July 27, 2018, FDA issued a Form 483 with 2 observations to Unichem Laboratories Limited in Pithampur, India after an inspection that ran Jul 27, 2018. The investigator was William Leonard. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning procedures are not…
- 02
Test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmUnichem Laboratories Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unichem Laboratories Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Unichem Laboratories Limited?
William Leonard is named on this Form 483, for the inspection of Jul 27, 2018. Each investigator has a profile showing what they cite most.
When was Unichem Laboratories Limited inspected by FDA?
The inspection ran Jul 27, 2018, and the Form 483 is dated July 27, 2018.
How do I get the full Form 483 for Unichem Laboratories 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.