Lotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block
Form 483 issued August 22, 2017 · Bangalore, India
- Inspection
- Aug 16 – Aug 22, 2017
- Investigator
- Alice A. Adams
- Observations
- 1
- Pages
- 3
- FEI number
- 3006323506
In short: On August 22, 2017, FDA issued a Form 483 with 1 observation to Lotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block in Bangalore, India (FEI 3006323506) after an inspection that ran Aug 16 – Aug 22, 2017. The investigator was Alice A. Adams. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 50.20 (general requirements for informed consent).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 50.20 (1×) · 50.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A. You performed study-specific screening procedures without…
This inspection in context
Alice A. Adams
1 document · 2017
Cites 50.20 (general requirements for informed consent) more than any other section. Most of their documents are for sites in India.
The firmLotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block history
The site's inspection history, in date order.
Similar 483sOther sites cited under 50.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 50.20 (general requirements for informed consent). The opening words of each observation are shown on this page.
Who inspected Lotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block?
Alice A. Adams is named on this Form 483, for the inspection of Aug 16 – Aug 22, 2017. Each investigator has a profile showing what they cite most.
When was Lotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block inspected by FDA?
The inspection ran Aug 16 – Aug 22, 2017, and the Form 483 is dated August 22, 2017.
How do I get the full Form 483 for Lotus Labs Private Limited 141/2, John Nagar, Koramangala II] Block?
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.