Mylan Pharmaceuticals Inc.
Form 483 issued July 17, 2015 · San Carlos, California
- Inspection
- Jul 8 – Jul 17, 2015
- Investigators
- Darren S. Brown· Lucila B. Nwatu· Robert D. Tollefsen
- Observations
- 5
- Pages
- 3
- FEI number
- 3007886374
In short: On July 17, 2015, FDA issued a Form 483 with 5 observations to Mylan Pharmaceuticals Inc. in San Carlos, California (FEI 3007886374) after an inspection that ran Jul 8 – Jul 17, 2015. The investigators were Darren S. Brown, Lucila B. Nwatu and Robert D. Tollefsen. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
4 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The written stability program does not assure testing of the drug product in the same container-closure…
- 02
The written stability program for drug products does not describe the storage conditions for…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
Reserve drug product samples are not representative of each lot or…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMylan Pharmaceuticals Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan Pharmaceuticals Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Mylan Pharmaceuticals Inc.?
Darren S. Brown, Lucila B. Nwatu and Robert D. Tollefsen are named on this Form 483, for the inspection of Jul 8 – Jul 17, 2015. Each investigator has a profile showing what they cite most.
When was Mylan Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jul 8 – Jul 17, 2015, and the Form 483 is dated July 17, 2015.
How do I get the full Form 483 for Mylan Pharmaceuticals Inc.?
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