Mylan Laboratories Limited
Form 483 issued February 1, 2017 · Bollaram, Jinnaram Mandal, Medak District, India
- Inspection
- Jan 24 – Feb 1, 2017
- Investigators
- Daniel J. Roberts· Liming Zhang
- Observations
- 1
- Pages
- 4
- FEI number
- 3007720135
In short: On February 1, 2017, FDA issued a Form 483 with 1 observation to Mylan Laboratories Limited in Bollaram, Jinnaram Mandal, Medak District, India (FEI 3007720135) after an inspection that ran Jan 24 – Feb 1, 2017. The investigators were Daniel J. Roberts and Liming Zhang. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems. Input to and output from the…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
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 facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Daniel J. Roberts and Liming Zhang are named on this Form 483, for the inspection of Jan 24 – Feb 1, 2017. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran Jan 24 – Feb 1, 2017, and the Form 483 is dated February 1, 2017.
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.