The ingredients in your nonpharmaceutical products could contaminate the drug products that you manufacture on shared equipment, such as the various drugs for oral use discussed above. This product is labeled as “Caution: Keep away from children, do not consume and avoid contact with eyes.” ![]() You manufacture finished drug products, including toothpaste and mouth rinse products containing sodium fluoride, stannous fluoride, and potassium nitrate using the same equipment you use to manufacture numerous nonpharmaceutical materials in your facility, including (b)(4). Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)). We reviewed your Septemresponse to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.ĭuring our inspection, our investigators observed specific violations including, but not limited to, the following.ġ. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).īecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 2nd Street, Rogers, from August 29 to September 2, 2022. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dunagin Pharmaceuticals Inc. Ĭlose used items inside plastic tube and dispose safely.Issuing Office: Division of Pharmaceutical Quality Operations II To detect all ingredients and estimate their amount pair reagents with a TLC purity test kit. Adulterants can be detected with reagents only if they cause a darker color change than the expected substance. Reagents can indicate PRESENCE, but not PURITY or QUANTITY. Take photos.Ĭompare color change with instructions. Over time reaction will degrade due to air contact. Do not overinterpret your results, consider that color change reaction is always fastest and most vivid in the part where biggest surface of reagent touches sample, compared to its edges. OBSERVE FOR UP TO 3 MINUTESĭisregard any color change after 3 minutes. Using included plastic spatula add prepared small ( Do not crush the glass ampoule, after a few soft pushes and 10-20 seconds of trying the ampoule head will snap off without any effort. ![]() ADD PREPARED SAMPLE TO REAGENTīreak open glass ampoule by gently pushing bottom of plastic cap outwards with your thumb pointing down. A bigger sample can cause a stronger reaction. If testing a liquid, dry one drop on paper or clean ceramic surface. If testing a pill, powder or crystal, crush it finely. Get your sample, reagent ampoule, a sharp tool / scoop and paper towels. Zimmermann / Beam – main test for cathinones and benzodiazepines in geneal, detects also CBDįentanyl Test Strip to detect fentanyl, even if it is mixed in another substance.MDMA, meth, mephedrone, methylone or PMMA Simon – main test for secondary amines, e.g.Robadope – main test for primary amines, e.g.Morris – main test for cocaine and ketamine, can tell apart some novel dissociatives.Mecke – main test for most powders, secondary test for cocaine, ketamine and mephedrone.Marquis – main test for most powders, secondary test for ketamine, mephedrone and psychedelics.Liebermann – main test for most powders, secondary test for cocaine (detects levamisole). ![]() Froehde – main test for most powders, secondary test for ketamine and amphetamines, long shelf life.Hofmann – main test for lysergamides and tryptamines, more precise but slower than Ehrlich.lysergamides and tryptamines but also 5-HTP and more, secondary test for cocaine Ehrlich – main test for all indoles, e.g.Cannabis (4-AP)– main test for THC / CBD, helps rule out synthetic cannabinoids.To view the chart below on mobile switch to landscape mode or preferably to a larger screen. ➕ = positively indicates presence of some adulterants (see footnotes). ➖ = not applicable. At least 2 are recommended to reduce the risk of inconclusive result. ➕➕ = positively indicates presence of expected substance. PRO 2C-B Reagent Test is best for 2C-B, MDMA, MDA or meth/amphetamine but it’s also suitable for benzofurans, cathinones and opioids.
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