Sloppy Sterility Seen At US OTC Ophthalmic Firm
Mexican Sanitizer Maker Also Warned About Sterile Conditions, Halts Production
Sterling Pharmaceutical’s Restricted Access Barrier Systems “permitted access to the processing line … without the design of rigid wall enclosures,” FDA says. Eksa Mills makes cleaning solutions with the same equipment in same facility and didn’t maintain written cleaning procedures or equipment use logs.
