FDA WARNING_LETTER - Kings Park Slope Inc - March 14, 2014

This FDA Warning Letter (NYK 2015-28) was issued to Kings Park Slope, Inc. (dba Kings Pharmacy), an outsourcing facility, following an inspection from March 4-14, 2014. The inspection revealed serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations include: - **Insanitary Conditions (FDCA 501(a)(2)(A)):** Operators produced sterile drugs with exposed skin, non-sterile gowns/facemasks, and non-sterile gloves in ISO 5 areas. The firm also failed to demonstrate adequate protection of ISO 5 areas by hoods. - **CGMP Violations (FDCA 501(a)(2)(B)):** Failure to establish and follow written procedures to prevent microbiological contamination (21 CFR 211.113(b)), ensure appropriate personnel clothing (21 CFR 211.28(a)), and establish an adequate environmental monitoring system (21 CFR 211.42(c)(10)(iv)). - **Failure to Meet 503B Conditions:** - Drug product labeling lacked "This is a compounded drug" (FDCA 503B(a)(10)). - Failure to submit required 6-month drug product reports upon initial registration (December 2013) and in June 2