Mylan Laboratories Limited
Form 483 issued September 14, 2016 · Sinnar, India
- Inspection
- Sep 5 – Sep 14, 2016
- Investigator
- Massoud Motamed
- Observations
- 1
- Pages
- 10
- FEI number
- 3005587313
In short: On September 14, 2016, FDA issued a Form 483 with 1 observation to Mylan Laboratories Limited in Sinnar, India (FEI 3005587313) after an inspection that ran Sep 5 – Sep 14, 2016. The investigator was Massoud Motamed. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. (a)…
This inspection in context
Massoud Motamed
20 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
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 211.165(e)
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 laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Massoud Motamed is named on this Form 483, for the inspection of Sep 5 – Sep 14, 2016. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran Sep 5 – Sep 14, 2016, and the Form 483 is dated September 14, 2016.
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.