U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality Guidance for Industry June 2013

Final
Docket Number:
FDA-2012-D-0083
Issued by:
Guidance Issuing Office
Office of Foods and Veterinary Medicine, Center for Veterinary Medicine
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0083.