Mylan Pharmaceuticals, Inc.
Form 483 issued April 12, 2018 · Morgantown, West Virginia
- Inspection
- Mar 19 – Apr 12, 2018
- Investigators
- Alison N. Stieg· Atul J. Agrawal· Ileana Barreto-Pettit
- Observations
- 13
- Pages
- 32
- FEI number
- 1110315
In short: On April 12, 2018, FDA issued a Form 483 with 13 observations to Mylan Pharmaceuticals, Inc. in Morgantown, West Virginia (FEI 1110315) after an inspection that ran Mar 19 – Apr 12, 2018. The investigators were Alison N. Stieg, Atul J. Agrawal, Ileana Barreto-Pettit, James M. Mason, Ko U. Min, Marcus A. Ray, Melissa T. Roy and Rebecca E. Dombrowski. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and production account for 8 of 13 observations.
Most cited: 21 CFR 211.67 (3×) · 211.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Alison N. Stieg
1 document · 2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in West Virginia.
The firmMylan Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan Pharmaceuticals, Inc.?
FDA listed 13 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Mylan Pharmaceuticals, Inc.?
Alison N. Stieg, Atul J. Agrawal, Ileana Barreto-Pettit, James M. Mason, Ko U. Min, Marcus A. Ray, Melissa T. Roy and Rebecca E. Dombrowski are named on this Form 483, for the inspection of Mar 19 – Apr 12, 2018. Each investigator has a profile showing what they cite most.
When was Mylan Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 19 – Apr 12, 2018, and the Form 483 is dated April 12, 2018.
How do I get the full Form 483 for Mylan Pharmaceuticals, Inc.?
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.