FDA WARNING_LETTER - Concord, Inc. dba Carlton's Dunwoody Pharmacy - January 13, 2016

An FDA inspection of Carlton's Dunwoody Pharmacy Corp. from January 5-13, 2016, revealed that drug products were produced without valid prescriptions for individually-identified patients, failing to meet Section 503A of the FDCA. This renders the compounded drugs ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements.

Specific violations include: - **Adulterated Drug Products (Section 501(a)(2)(B) FDCA):** Significant CGMP violations were observed, such as failure to establish a written stability testing program (21 CFR 211.166(a)), quality control unit's failure to approve/reject procedures (21 CFR 211.22(c)), incomplete batch production records (21 CFR 211.188), and use of non-conforming instruments (21 CFR 211.160(b)(4)). - **Misbranded Drug Products (Section 502(f)(1) FDCA):** Ineligible drug products lacked adequate directions for use, as they are not amenable to self-diagnosis and treatment.

The firm's January 21, 2016, response to the FDA 483 did not address discontinuing compounding without valid prescriptions. If compounding continues without meeting Section 503A conditions, the firm must comply