Micro Labs Limited
Form 483 issued May 30, 2025 · Verna, India
- Inspection
- May 21 – May 30, 2025
- Investigator
- Lauren N. Howard
- Observations
- 2
- Pages
- 4
- FEI number
- 3005210225
In short: On May 30, 2025, FDA issued a Form 483 with 2 observations to Micro Labs Limited in Verna, Goa (FEI 3005210225) after an inspection that ran May 21 – May 30, 2025. The investigator was Lauren N. Howard. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
The firmMicro Labs 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Micro Labs Limited?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Micro Labs Limited?
Lauren N. Howard is named on this Form 483, for the inspection of May 21 – May 30, 2025. Each investigator has a profile showing what they cite most.
When was Micro Labs Limited inspected by FDA?
The inspection ran May 21 – May 30, 2025, and the Form 483 is dated May 30, 2025.
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.