FDA WARNING_LETTER - Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy - May 22, 2017

An FDA inspection of Mark Drugs Pharmacy (Snyder Mark Drugs Roselle, Inc.) from April 26 to May 22, 2017, revealed serious deficiencies in sterile drug product production and failure to meet Section 503A of the FDCA. The firm did not receive valid prescriptions for individually-identified patients for a portion of its compounded drugs, rendering them ineligible for exemptions from CGMP, adequate labeling, and FDA approval.

Violations included insanitary conditions, such as operators blocking unidirectional airflow, failing to sanitize gloves, wearing non-sterile gloves during aseptic production, and exposing sterile products to substandard air quality. The firm also failed to adequately monitor pressure differentials and demonstrate proper protection of ISO 5 areas.

For ineligible drug products, significant CGMP violations were cited, including failure to establish and follow procedures for preventing microbiological contamination (21 CFR 211.113(b)), ensure appropriate personnel clothing (21 CFR 211.28(a)), maintain equipment for aseptic conditions (21 CFR 211.42(c)(10)(vi)), monitor environmental conditions (21 CFR 211.42(c)(10)(iv)), conduct final product testing (21 CFR 211.167(a)), and establish stability testing programs (21 CFR 211.166(a)). These products are considered adulterated, un