FDA WARNING_LETTER - Dercher Enterprises, Inc., DBA Gordon Laboratories - March 29, 2019

The FDA issued a Warning Letter to Gordon Laboratories following a March 2019 inspection, citing significant CGMP violations for finished pharmaceuticals (21 CFR parts 210 and 211). The firm's drug products, including Monsel's Solution, were deemed adulterated. CGMP deficiencies included a failure to thoroughly investigate unexplained discrepancies and recurring super-potency issues with Monsel’s Solution (21 CFR 211.192). The firm also failed to conduct appropriate microbiological testing, resulting in contamination of Monsel’s Solution (21 CFR 211.165(b)). Furthermore, Gordon Laboratories lacked an adequate quality control unit and failed to establish and follow adequate written procedures (21 CFR 211.22(a) & 21 CFR 211.22(d)), impacting CAPA, material storage, and vendor qualification. Beyond CGMP, the letter cited "TRI-CHLOR," "SILVER NITRATE SOLUTION 10%," "SILVER NITRATE SOLUTION 25%," and "SILVER NITRATE SOLUTION 50%" as unapproved new drugs, marketed without FDA approval (sections 505(a) and 301(d) of the FD&C Act). Additionally, "TRI-CHLOR," "SILVER NITRATE SOLUTION 25%," and "SILVER NITRATE SOLUTION 50%" were misbranded, lacking adequate directions for use for laymen as they are prescription drugs (section 502(f)(1) of the FD&C Act). The FDA requires prompt corrective actions, a detailed response within 15 working days, and strongly recommends a CGMP consultant. Non-compliance could lead to legal action, including product seizure, injunctions, and denial of applications or export certificates.