Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality Guidance for Industry June 2013
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineCenter for Drug Evaluation and ResearchCenter 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.
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:
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.