The Medicines Company
Form 483 issued April 17, 2015 · Redwood City, California
- Inspection
- Apr 8 – Apr 17, 2015
- Investigator
- Mary R. Hole
- Observations
- 8
- Pages
- 5
- FEI number
- 3011458601
In short: On April 17, 2015, FDA issued a Form 483 with 8 observations to The Medicines Company in Redwood City, California (FEI 3011458601) after an inspection that ran Apr 8 – Apr 17, 2015. The investigator was Mary R. Hole. Most observations concern management controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Management controls and design controls account for 5 of 8 observations.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Design verification does not confirm that design output…
- 02
Procedures for design transfer have…
- 03
Procedures for finished device acceptance have…
- 04
Corrective and preventive action activities and/or results have…
This inspection in context
Mary R. Hole
7 documents · 2013–2017
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmThe Medicines Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Medicines Company?
FDA listed 8 observations on this Form 483, mostly about management controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected The Medicines Company?
Mary R. Hole is named on this Form 483, for the inspection of Apr 8 – Apr 17, 2015. Each investigator has a profile showing what they cite most.
When was The Medicines Company inspected by FDA?
The inspection ran Apr 8 – Apr 17, 2015, and the Form 483 is dated April 17, 2015.
How do I get the full Form 483 for The Medicines Company?
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.