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  • Form Fda 3177. Recall Audit Check Report

Get Form Fda 3177. Recall Audit Check Report

1. RECALL INFORMATION a. RES NUMBERb. RECALLING FIRM2. PROGRAM DATA (FDA Users Only)a. MONITORING DIVISIONc. RECALLED CODE(S)d. PRODUCT(S)3. AUDIT ACCOUNTS a. DIRECTb. SUBACCOUNT (SECONDARY)PHONE.

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FDA regulated firms may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception or are otherwise defective.

Effectiveness Checks A recall is considered complete after all of the company's corrective actions are reviewed by FDA and deemed appropriate. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place.

Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Step 1: Don't panic! ... Step 2: Don't eat the food. ... Step 3: Don't open the food. ... Step 4: Check the recall notice to find out what to do with the food.

Firm-initiated recall If a firm does this because it believes its product is violative, it is required to immediately notify the FDA. You must contact your FDA's Office of Regulatory Affairs (ORA) Division Recall Coordinator (DRC) listed here by state or region (look for Product Type Medical Device ).

Class II. Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. One example is a drug that is under-strength but that is not used to treat life-threatening situations.

Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

In addition, the FDA posts consumer information about Class I and some Class II and III recalls in order to ensure that patients are aware of the seriousness of the potential health hazard posed by exposure to the product.

FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products. ... FDA has issued a mandatory recall order of a food product only once.

Step 1: Don't panic! ... Step 2: Don't eat the food. ... Step 3: Don't open the food. ... Step 4: Check the recall notice to find out what to do with the food.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232