Micro Labs Limited
Form 483 issued February 9, 2024 · Verna, India
- Inspection
- Jan 29 – Feb 9, 2024
- Investigators
- Patty P. Kaewussdangkul· Pratik S. Upadhyay
- Observations
- 6
- Pages
- 25
- FEI number
- 3005210225
In short: On February 9, 2024, FDA issued a Form 483 with 6 observations to Micro Labs Limited in Verna, Goa (FEI 3005210225) after an inspection that ran Jan 29 – Feb 9, 2024. The investigators were Patty P. Kaewussdangkul and Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Equipment and utensils are not cleaned and maintained at appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Micro Labs Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Micro Labs Limited?
Patty P. Kaewussdangkul and Pratik S. Upadhyay are named on this Form 483, for the inspection of Jan 29 – Feb 9, 2024. Each investigator has a profile showing what they cite most.
When was Micro Labs Limited inspected by FDA?
The inspection ran Jan 29 – Feb 9, 2024, and the Form 483 is dated February 9, 2024.
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.