Mylan Laboratories Limited
Form 483 issued February 28, 2020 · Bengaluru, India
- Inspection
- Feb 20 – Feb 28, 2020
- Investigators
- Linda F. Murphy· Steven M. Weinman
- Observations
- 5
- Pages
- 6
- FEI number
- 3007648351
In short: On February 28, 2020, FDA issued a Form 483 with 5 observations to Mylan Laboratories Limited in Bengaluru, Karnataka (FEI 3007648351) after an inspection that ran Feb 20 – Feb 28, 2020. The investigators were Linda F. Murphy and Steven M. Weinman. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
ENPLOYEE(S) SIGNATURE Written records of investigations into unexplained discrepancies and the failure of a batch or…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmMylan Laboratories Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan Laboratories Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Linda F. Murphy and Steven M. Weinman are named on this Form 483, for the inspection of Feb 20 – Feb 28, 2020. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran Feb 20 – Feb 28, 2020, and the Form 483 is dated February 28, 2020.
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.