FDA WARNING_LETTER - Kadesh International - November 07, 2018

The FDA inspected Kadesh Inc.'s drug manufacturing facility from October 19 to November 7, 2018, identifying significant CGMP violations. The firm's drug products are adulterated under 21 U.S.C. 351(a)(2)(B). Specifically, "Puriton Eye Relief Drops" and "Puriton Intimate Disinfection Spray" are misbranded for lacking the "Rx only" symbol (21 U.S.C. 353(b)(4)), and "Puriton Natural Mineral Cleansing Bar Soap" is an unapproved new drug (21 U.S.C. 355(a), 331(d)).

Violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** Kadesh Inc. failed to establish proper QU roles, released non-sterile ophthalmic products, and lacked oversight of contract manufacturers, who filled drugs in non-sterile facilities. The ophthalmic product also had an unacceptably alkaline pH. 2. **Incomplete Batch Production and Control Records (21 CFR 211.188):** The firm released bulk ophthalmic drug product without preparing batch records and failed to document manufacturing steps. 3. **Failure to Establish Time Limits (21 CFR 211.111):** No time