Advanced Sterilization Products, an Irvine-based unit of Johnson & Johnson, received a warning letter from the Food and Drug Administration concerning manufacturing issues.
In the letter, the FDA said it was calling for further inspection and an outside audit and certification of ASP, which makes devices for sterilizing medical instruments.
Regulators found multiple problems at ASP, including failures to verify design changes needed to make sure devices work properly, the FDA said in the letter, which was dated March 12 and made public Tuesday.
The FDA also said in its letter that ASP didn’t ensure that finished devices met necessary requirements.
Some of ASP’s responses to concerns that regulators raised have been inadequate so far, the FDA said in the letter.
A follow-up FDA inspection of ASP will be required, the agency said in the letter.
ASP’s sterilizers and cleaning devices are sold under the Sterrad, Evotech and Cidex brands.
It operates out of a complex on Technology Drive in the Irvine Spectrum that houses functions such as manufacturing, research and development and corporate operations.
