Man­u­fac­tur­ing sites in Ger­many and Chi­na hit with warn­ing let­ters over QC and clean­ing is­sues

Two sep­a­rate drug man­u­fac­tur­ers have been cit­ed by US reg­u­la­tors over sev­er­al in­frac­tions in­clud­ing qual­i­ty, clean­ing and oth­er is­sues.

The FDA on Tues­day re­leased two warn­ing let­ters to Chi­nese API pro­duc­er Zhe­jiang Tianyu Phar­ma­ceu­ti­cal Co and Ger­many-based OTC drug man­u­fac­tur­er Sys­temKos­metik.

The let­ter is­sued to Sys­temKos­metik ear­li­er this month stat­ed that the com­pa­ny’s fa­cil­i­ty in Mun­ster, Ger­many has sev­er­al cGMP vi­o­la­tions against it such as not hav­ing writ­ten pro­ce­dures for pro­duc­tion and process con­trol and no writ­ten pro­ce­dures for equip­ment clean­ing and main­te­nance where the com­pa­ny makes its OTC prod­ucts.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER