FDA recall - docstoc

Docstoc is a user community for sharing documents. Find free documents and upload your docs for all to share.

by relevance

search results

<< prev 1...

preview

FDA s Clarification of Aripiprazole Tablets Bioequivalence Requirementse

DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD 20857September 28, 2006Reference Number: Dear Aripiprazole ANDA Applicant: This letter i... ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

FORM FDA RECALL AUDIT CHECK REPORT

1. RECALL INFORMATION a. RECALL NUMBER b. RECALLING ESTABLISHMENT2. PROGRAM DATA (CHECK BOX IF PREVIOUSLY SUBMITTED) (DO NOT COMPLETE IF REPORTED UNDER FDA 2123) a. ACCOMP DISTRICT CODE b. HOME ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Recall Alert Information

Attachment A ??? Recall Alert Information Submit the information listed below to the CRU and OE/DCMO via RES: ??? Product(s) Description ??? Codes ??? Recalling Firm ??? Short Reason for Recall ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Requested recall shellhigh

07083 Dear Dr. Gabbay:- 2 2007FDA requests that Shelhigh, Inc. initiate an immediate recall of all devices manufactured by your firm in Union, New Jersey. The products to recall include: Shelhigh ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Recommendation for Recall Classification

Attachment B - Recommendation for Recall Classification Update and transmit the electronic record in RES with the required information necessary for the CRU to review and classify the recall. RES ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Hearltland recall notice

URGENT: DRUG RECALLHRS Lot All lot numbers beginning with the letter ???K??? Example K... lot number beginning with ???K???. The specific products and lot numbers subject to this recall can ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Baxter

Baxter Hea/Ihcare Corporation Route 120 & Wdsoo Road Round Lake. IIIirK)is 60073-0490847.546.6311September 28, 2005Re:Proper Routing of Blood Tubing Set for MERIDIAN ... ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Recommendation for Recall Classification and Termination

Attachment B1 - Recommendation for Recall Classification and Termination Note: Under RES, this information will be a continuation of the electronic recall record and many of these fields will be pre ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Methods for Conducting Recall Effectiveness Checks

Attachment H ???Methods for Conducting Recall Effectiveness Checks INTRODUCTION In the Federal Register of June 16, 1978, (43FR26202), The Food and Drug Administration (FDA) issued as a final rule ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Recall Termination or Recommendation for Termination

Attachment C - Recall Termination or Recommendation for Termination A Recall Termination (Summary) or Termination Recommendation must be prepared and submitted for those recall actions not terminated ... more>>

tags:food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety

categories:legal > Government >

preview

Recall information from Baxter

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial ProductsBaxter Worldwide... > About Baxter > News Room > News Releases > ...Baxter to Proceed with Recall of Remaining ... more>>