Donation FACTS
A+, B+, O+, AB+ and this type are blood types recommended for platelet donation
What is AB-
These types of reports must be submitted within 45 days of discovery.
What are BPDr or Biological Product Deviation reports
A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2)
What is a BLA
This disease is a tick-borne zoonosis caused by infections of humans with intraerythrocytic protozoa of the genus with a similar name.
What is Babesiosis
FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations found in what title of the code of federal regulations.
What is Title 21
These blood products are used to help stop bleeding in people who have cardiac surgery.
What are Platelets
FDA requires reporting of a malfunction of these types of devices when they have caused a death or serious injury.
What is a medical device.
Agency of the United States Department of Health and Human Services whose principal purpose is to enforce the Federal Food, Drug and Cosmetic Act
Who is the FDA
This virus is primarily transmitted by Aedes mosquitoes, most commonly Aedes aegypti and infection to humans during pregnancy can cause microcephaly, severe congenital defects, and infant death.
What is zika virus or ZIKV
Part 600 of Title 21 of the CFR covers the general requirements for the manufacture of this general product type monitored by CBER.
What is Biologics
You can donate platelets this often to provide products up to 24 times a year
What is every 7 days
You must have one of these displaying on the product label if you want to send biologic products over state lines.
What is a license
This group regulates biological products. The current authority for this responsibility resides in Section 351 of the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.
Who is CBER
This disease is caused by the protozoan parasite an is endemic in Mexico and Central and South America. Natural infections are transmitted by infected blood sucking insects(kissing but or triatomine)
What is Chagas
Title 21 Part 211 of the CFR provides the minimum manufacturing requirements for the preparation of drug products for administration to humans or animals and is collectively called by this four-letter term.
What is cGMP
This organ pumps 2000 gallons of blood each day
What is the heart
FDA notifies manufacturers using this type of document when the FDA finds that a manufacturer has significantly violated FDA regulations.
What is a warning letter
A unique identifier issued by the FDA to track inspections of the regulated establishment or facility. These are also used to track GDUFA facility fee payments.
What is an FEI number
It can take 3 to 12 weeks for a person’s body to make enough of these for an ELISA, EIA or ChLIA test to detect HIV infection.
What are antibodies
Part 1271 regulations are applicable to drugs that are also human cells, tissues, and cellular and tissue-based products, abbreviated as this.
What is HCT/P
The number of days a donor must wait to donate the next whole blood product that can save up to 3 lives.
What is 56 days
FDA just provided a Form-482 to a facility. What are they notifying the facility of?
What is a notice of Inspection
This is additional information provided to CBER based on the recall classification for the BPD report submitted. Could be mistaken for Artificial Intelligence.
What is an AI
This type of testing can detect HIV the fastest by looking for the virus in the blood. It can take 7 to 28 days for this test to detect HIV.
What is NAT or NAAT(nucleic acid test or Nucleic acid amplification test)
Subpart F identifies production and this type of control and includes that any deviation from the written procedures shall be recorded and justified.
What is Process control