Micro Labs Limited
Form 483 issued December 8, 2023 · Bengaluru, India
- Inspection
- Dec 4 – Dec 8, 2023
- Observations
- 3
- Pages
- 3
- FEI number
- 3004939494
In short: On December 8, 2023, FDA issued a Form 483 with 3 observations to Micro Labs Limited in Bengaluru, Karnataka (FEI 3004939494) after an inspection that ran Dec 4 – Dec 8, 2023. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 2 of 3 observations.
Most cited: 21 CFR 211.42 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to use dedicated production areas, including facilities and air…
- 02
Failure to ensure that, for each batch of intermediates, API intermediates and APIs, appropriate laboratory tests…
- 03
Failure to demonstrate tha{5)(@)sea in the manufacturing of your API and intermediates is suitable…
This inspection in context
Questions about this 483
What did FDA find at Micro Labs Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Micro Labs Limited inspected by FDA?
The inspection ran Dec 4 – Dec 8, 2023, and the Form 483 is dated December 8, 2023.
How do I get the full Form 483 for Micro Labs 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.