Region Care, Inc. – FDA Warning Letter, Mar 20, 2014

This FDA Warning Letter (NYK-2015-29) was issued to Region Care, Inc., an outsourcing facility registered under section 503B of the FDCA, following an inspection from March 4-20, 2014. The inspection revealed serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations include: - **Insanitary Conditions (501(a)(2)(A) FDCA):** Observed rust in sterile production hoods and failure to demonstrate adequate protection of ISO 5 areas, indicating contamination risk. - **CGMP Violations (501(a)(2)(B) FDCA):** Failure to investigate discrepancies (21 CFR 211.192), lack of validated aseptic/sterilization procedures (21 CFR 211.113(b)), inappropriate personnel clothing (21 CFR 211.28(a)), poor facility repair (21 CFR 211.58), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), and lack of final product conformance testing (21 CFR 211.167(a)). - **Failure to Meet 503B Conditions:** Drug product labels lacked "This is a compounded drug," phone number, or date of compounding (503B(a)(10