The Medicines Company

FDA inspection history in Redwood City, California, 2015

1
Form 483

Every document, by year

  • Form 483

2015: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One Form 483, at Redwood City, California.

Cited most

Across all The Medicines observations on file

The complete The Medicines file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2015-04-17483 Form 483$99

Investigators on these documents

Mary R. Hole (1)

FEI number 3011458601 · most recent document Apr 17, 2015

About The Medicines Company

How many FDA Form 483s has The Medicines Company received?

FDA Intel has 1 Form 483 on file for The Medicines Company; the most recent is dated Apr 17, 2015.

When was The Medicines Company last inspected by FDA?

The most recent FDA inspection document on file for The Medicines Company is a Form 483 dated Apr 17, 2015, for the site in Redwood City, California.

What did FDA cite at The Medicines Company?

The regulations cited most in the observations on file for The Medicines Company are 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.22 (Quality audit), 2 times; 21 CFR 820.30(f) (Design controls), 2 times.