FDA WARNING_LETTER - Ridge Properties, LLC - March 16, 2017

The FDA issued a Warning Letter to Ridge Properties, LLC dba Pain Relief Naturally following an inspection from February 28 to March 16, 2017, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). The firm's drug products are deemed adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, the firm manufactures unapproved new drugs (21 U.S.C. § 355(a)) and misbranded drugs (21 U.S.C. §§ 352(b)(1), 352(x)).

Key violations include: 1. **Lack of Product Testing:** The firm failed to test drug products for identity, strength, and microbial attributes (21 CFR 211.165(a) and (b)). FDA testing found Extra Strength PreTAT Gel (lot 1043) to be subpotent and separated. 2. **Inadequate Complaint Handling:** Over 50 complaints regarding "ineffectiveness" and "inadequate numbing strength" for 4% lidocaine TAT Balm products in 2016 were not adequately investigated, including testing of complaint samples (21 CFR 211.198(a)). 3.