FDA WARNING_LETTER - tsdr pharmacy inc. - March 28, 2017

An FDA inspection of TSDR Pharmacy, Inc. DBA brandMD Skin Care from March 20-28, 2017, revealed serious deficiencies in producing non-sterile drug products, posing patient risks. The firm's compounded drug products failed to meet Section 503A conditions of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients for a portion of its products. This renders these products ineligible for exemptions from CGMP, adequate directions for use, and FDA approval requirements.

Violations included drug products being adulterated under Section 501(a)(2)(A) due to insanitary conditions, such as black oily residue on equipment and a lack of cleaning procedures. Significant CGMP violations were also observed, including failures to establish and follow adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)), establish laboratory controls (21 CFR 211.160(b)), establish a quality control unit (21 CFR 211.22(a)), establish adequate production and process control procedures (21 CFR 211.100(a)), and routinely calibrate equipment (21 CFR 211.68(a)).

Furthermore, the firm lacked FDA-approved applications for its ineligible compounded drugs, making them unapproved new drugs under Sections 505(a) and 301(d). These products were also deemed misbranded under Section 502(f)(1) because they lacked adequate directions for use for conditions not amenable to self-diagnosis.

FDA found the firm's April 11, 2017, response inadequate, particularly regarding insanitary conditions and the distribution of