Insufficient equipment cleaning led a California API maker to recall several lots of Simethicone Emulsion USP (30%) that had microbial contamination.
An FDA warning letter, posted to its site today, says NuSil Technology is not meeting a number of standards that would prevent further contamination of products made at its plant in Bakersfield, CA.
The company found that failure to sanitize a transfer hose was probably the reason Burkholderia cepacia was found in the product, but it can't be sure because it hasn't taken steps to get at the "root cause" of out-of-spec lots. The company instead has released products based on hitting the right markers in retests.
NuSil was relying on pH and temperature controlling steps without a validation protocol and without identifying its parameters during the time the contamination occurred, the FDA notes. Further, the inspection report says "your manufacturing process has multiple steps after your pH and heating step that would provide vectors for microbial contamination."
The FDA has found other problems as well and says the company's responses are lacking. It has told the company to come up with a complete response that lays out exactly how it will address the sanitation issues and be able to get at their cause, should there be out-of-specification results in later processing.
- here's the FDA letter