Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

A Rose is Not a Rose: All ISO 13485 Certifications Are Not Equal

Posted by crimsonlanguage on 2011/09/09

The FDA just delivered a scathing 483 to device maker Pharmaceutical Innovations of New Jersey, citing, among other blatant violations:

Lack of calibration or maintenance of in-house sterilizers, lack of validated processes, lack of sterilization verification testing, no DMR/DHF, lack of sterilization batch information, and openly destroying legally required production records rather then permit FDA review (!) – the full text 483 is here.

The situation that set up the for-cause FDA inspection was particularly alarming. As stated in the letter, several infants in a neonate ICU (NICU) cultured positive for Pseudomonas (potentially lethal for immuno-compromised individuals, like premature infants!). The hospital’s investigation led to culturing the company’s ultrasound 8 oz bottles and 5 liter gel which tested positive for the Pseudomonas organism. You can see a company video touting their latest product, designed for (you guessed it)  infants is here.

Apart from the seeming lack of quality system rigor that seriously jeopardized some of the most vulnerable patients imaginable – it was especially alarming to see that this company was registered to ISO 13485…by Orion Registrar.

In fact, I’ve written before about the importance of ensuring that your suppliers are certified by a reputable registrar (e.g. DEKRA, BSI, etc) – and doing your own audit verification. For translation suppliers, this means examining Management Reports, CAPA records, project records, and other systems documentation to ensure that hazards are identified and mitigated.

Either that, or risk having a company like Pharmaceutical Innovations on your Approved Supplier List.


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