The FDA smacked Siemens Healthcare with the second warning letter in a month concerning quality and manufacturing issues with some of its diagnostics products.
The latest letter, issued June 29, targets the company's Newark, DE facility. Regulators say the division of Siemens ($SI), for example, failed to initiate "field corrections" for its Mass CKMB isoenzyme calibrator, choosing instead to "replace on complaint" and then scrap the product's remaining inventory, according to the letter. Siemens is cited for taking similar action regarding its Stratus CS nt-ProBNP test. After a number of complaints that the test malfunctioned, the company chose to replace the product as complains came in, rather than using "field corrections" to address the matter, the letter notes.
Regulators credit the company, however, for ending the "replace on complaint" procedure, but blast Siemens for not training employees on the new process.
The FDA doesn't stop there. Regulators also blast the company for not establishing adequate procedures to retest and reevaluate a product after reported problems and subsequent reworking. The letter also faults Siemens for faulty investigations into the two products' reported flaws and shoddy documentation about solutions taken. Regarding the Stratus product, the FDA additionally took Siemens to task for concluding how to fix the product's malfunction, but not taking two crucial steps to fix it, and "simply" accepting customers' complaints.
A month ago, the FDA cited Siemens for marketing its AD Via Centaur iPTH immunoassay to assess a number of ailments without formal approval, and also a number of quality violations regarding the product's manufacturing. A Siemens spokesman said then that the company was working to implement a number of the issues identified by the FDA.
Siemens must respond within 15 days of receiving its latest warning letter, and outline steps it is taking to fix the any FDA-cited problems.
- read the warning letter