Mylan LLC
Form 483 issued May 22, 2015 · Caguas, Puerto Rico
- Inspection
- May 7 – May 22, 2015
- Investigator
- Libia M. Lugo
- Observations
- 4
- Pages
- 6
- FEI number
- 2650176
In short: On May 22, 2015, FDA issued a Form 483 with 4 observations to Mylan LLC in Caguas, Puerto Rico (FEI 2650176) after an inspection that ran May 7 – May 22, 2015. The investigator was Libia M. Lugo. Most observations concern quality system.
At a glance
2 of 2 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
: There is a failure to thoroughly review the failure of a batch or any of…
- 04
: The responsibilities and procedures applicable to the quality control unit are not fully followed. Your…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMylan LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan LLC?
FDA listed 4 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Mylan LLC?
Libia M. Lugo is named on this Form 483, for the inspection of May 7 – May 22, 2015. Each investigator has a profile showing what they cite most.
When was Mylan LLC inspected by FDA?
The inspection ran May 7 – May 22, 2015, and the Form 483 is dated May 22, 2015.
How do I get the full Form 483 for Mylan LLC?
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.