FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval

On January 18, 2012, Asbury Park Press published an article regarding a recent warning letter sent by the U.S. Food and Drug Administration (F.D.A.) to DePuy Orthopaedics, Inc., a subsidiary company of Johnson & Johnson. In the letter, the F.D.A. cited the orthopedic company for selling 14 different types of medical devices without obtaining the agency’s pre-market approval. The F.D.A. further warned DePuy that its quality system for reviewing medical devices was not in compliance with the agency’s requirements.

In response to the F.D.A.’s warning letter, DePuy Orthopaedics expressed its belief that the devices in question were custom-made, and as such, were exempt from the agency’s approval process. The company further alleged that this exemption has been in place since 1976. The F.D.A. responded by stating that the devices in question did not meet the custom-made criteria, as these may have been made accessible to other physicians after being placed in the individual patient.

In recent years, the F.D.A. has increasingly scrutinized Johnson & Johnson regarding a number of its subsidiary companies. McNeil Consumer Healthcare, a subsidiary company of Johnson & Johnson, recently closed down a plant that manufactured Tylenol after F.D.A. inspectors discovered several deficiencies in the manufacture of this product. Furthermore, DePuy Orthopaedics, another subsidiary of Johnson & Johnson, has come under increased scrutiny for its manufacture of the ASR XL hip system. The device was recalled by DePuy in 2010.

See the full Asbury Park Press article at:

See the F.D.A. warning letter at:

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