Mylan Laboratories Limited
Form 483 issued May 15, 2026 · Sinnar, India
- Inspection
- May 4 – May 15, 2026
- Investigators
- Pratik S. Upadhyay· Unnee Ranjan
- Observations
- 1
- Pages
- 27
In short: On May 15, 2026, FDA issued a Form 483 with 1 observation to Mylan Laboratories Limited in Sinnar, India after an inspection that ran May 4 – May 15, 2026. The investigators were Pratik S. Upadhyay and Unnee Ranjan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.188 (1×)
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…
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 firmMylan Laboratories Limited history
All 5 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 Mylan Laboratories Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Pratik S. Upadhyay and Unnee Ranjan are named on this Form 483, for the inspection of May 4 – May 15, 2026. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran May 4 – May 15, 2026, and the Form 483 is dated May 15, 2026.
How do I get the full Form 483 for Mylan Laboratories 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.