FDA WARNING_LETTER - Jaychem Industries Ltd - July 10, 2014

The FDA issued a Warning Letter to Jaychem Industries, Ltd. following a July 7-10, 2014 inspection of their pharmaceutical manufacturing facility in Auckland, New Zealand. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under Section 501(a)(2)(B) of the FD&C Act. Additionally, their GolfersSkin™ SPF 30 Plus WR80 Sunscreen Lotion and Lip Balm products were found to be misbranded under Sections 502(a), 502(c), 502(f)(1), and 502(f)(2) of the FD&C Act.

CGMP violations included failure to ensure component quality, inadequate written control procedures during manufacturing (specifically for (b)(4) lotion, which was released regardless of (b)(4) results), failure to test finished batches for identity and strength of active ingredients, and lack of stability data to support product shelf life. The quality unit released batches despite these issues.

Misbranding violations for the GolfersSkin™ products included non-compliant labeling for "Broad Spectrum" and SPF statements (different font sizes/separation), missing water resistance information on the lip balm, incomplete directions for use (e.g., reapplication instructions, sun protection measures), misleading statements in the "Uses