Micro Labs Limited
Form 483 issued February 7, 2025 · Bengaluru, India
- Inspection
- Jan 30 – Feb 7, 2025
- Investigators
- Pratik S. Upadhyay· Timothy H. Vo
- Observations
- 4
- Pages
- 9
- FEI number
- 3004495158
In short: On February 7, 2025, FDA issued a Form 483 with 4 observations to Micro Labs Limited in Bengaluru, Karnataka (FEI 3004495158) after an inspection that ran Jan 30 – Feb 7, 2025. The investigators were Pratik S. Upadhyay and Timothy H. Vo. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory controls do not me hide the establishment of scientifically sound and appropriate test procedures designed…
- 03
Deviations from written test procedures and laboratory mechanisms are…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMicro Labs Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Micro Labs Limited?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Micro Labs Limited?
Pratik S. Upadhyay and Timothy H. Vo are named on this Form 483, for the inspection of Jan 30 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was Micro Labs Limited inspected by FDA?
The inspection ran Jan 30 – Feb 7, 2025, and the Form 483 is dated February 7, 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.