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Hi All,
This is INDEPENDENT work that you are certainly NOT going to see in conventional media.
Gifts of support are always very much appreciated...
 
Thank you,
Emily
 
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Johnson & Johnson Acquires Synthes ... and This Incredible List of US FDA Violations!
Johnson & Johnson spent $21.3 Billion to buy Synthes - with Synthes already having this very long list of FDA violations in U.S. West Chester, PA, United States facility.

Keywords: jnj, johnson and johnson, johnson & johnson, J&J, synthes, fda, violation
Date Created/Edited: March 23, 2012
 

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ACA the Affordable CORRUPTION Act
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Johnson & Johnson Victims at Risk of RE-Victimization (2016, August 22)
If you are currently a victim of a known harmful Johnson & Johnson subsidiary product and have high medical needs due to your injuries, you are at increased risk of becoming a victim of another known harmful Johnson & Johnson subsidiary product.
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Johnson & Johnson Ethicrap, I Mean EthiCON, More JNJ JUNK (2016, July 25)
As I've mentioned, Johnson & Johnson has so many bad products I have to put a bunch in each article now to try to keep up. Now for EthiCON crap.
Johnson and Johnson, Johnson & Johnson, ethicon, harmonic ace, morcellator, physiomesh, secure strap, stapler
 
Here is the list of violations cited by the FDA: Inspections, Compliance, Enforcement, and Criminal Investigations, Synthes USA HQ, Inc. 2/16/12
 
1. Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a)
 
2. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).
 
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
 
4. Failure to maintain a record of the investigation of a complaint by the formally designated unit identified in 21 CFR 820.198(a).
 

5. Failure to promptly review, evaluate, and investigate any complaint that represents an event which must be reported to FDA under 21 CFR 803 by a designated individual, as required by 21 CFR 820.198(d).
 
In addition, the FDA report concluded that previous response was not adequate, products are misbranded, Synthes did not submit supplemental information and did not submit all information required by the FDA. The closing of the letter leads me to believe that the problems are ongoing and have not been resolved.
 
Gee, all this sounds sooo familiar. Wonder if the FDA will have to take over this facility with our tax dollars in addition to the J&J facilities already under FDA control?
 
Resources:
1. Fu Yun Chee (2012, March 15). UPDATE 1-J&J set to win EU okay to buy Synthes-source. Reuters. Retrieved from http://www.reuters.com/article/2012/03/15/jj-synthes-eu-idUSL5E8EF6LX20120315
 
2. Kirk Sooter (2012, February 16). Inspections, Compliance, Enforcement, and Criminal Investigations. United States Food and Drug Administration. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm294688.htm
 
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