Sanofi warning letter and response. Go to: HYPERLINK \"http://www.fda.gov/ICECI/

Question

Sanofi warning letter and response. Go to:

HYPERLINK "http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312929.htm" http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312929.htm

Discuss FDA observations on violations regarding building, facilities, and equipment, and in the context of regulations in CFR21 Part 211 subparts C and D (211.42-211.72), and the Sanofi responses to the observations. Discuss also the facility and equipment concerns under “Microbiological Control” and Failure Investigations. Go to section 211.42 of CFR21 and pinpoint the specific facility feature/s that Sanofi was not in conformance with. You may speculate as to the content of the redacted (hidden/deleted) information represented by the (b)(4)s. Which center in the FDA issued the letter? Do not abbreviate. What are the two types of vaccines mentioned in the letter?

Arial 11 pts, 1.15 spacing. 1 page.

Explanation / Answer

The United States Food and Drug Administration (USFDA) is a federal agency that maintains the defined standards in all manufacturing departments of food and drug products. The agency followes a defined set of regulations, which has to be followed by all food and drug manufacturing industries. Of these, regulations in CFR21 Part 211 subparts C and D deals with the meeting the good manufactirng practices, and equipment cleaning and maintanance respectively.

Any food and drug manufacturing industry must agree with the terms and conditions of FDA if they want to sell their product in the United States. If violation or failure to meet the FDA standards is observed during an inspection, the industry will recieve the report specifying all the missing standards. The industry have to answer the reasons to failure and should also specify the due date within which necessary changes will be taken to meet the standards. The production permits may be withdrawn or product may be blocked during this period, until the necessary changes are employed to meet the standards.

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