1Deviation, CAPA, and investigation
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). You failed to provide adequate oversight of finished product testing, and other quality functions. For example, your Quality Unit (QU) failed to initiate and document an investigation into out-of-specification (OOS)…
2Material and supplier control
Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)). You relied on certificates of analysis (COA) for incoming components from your suppliers without establishing the reliability of your suppliers’ test results. Additionally, a representative COA noted the use of nonpharmaceutical grade potassium nitrate in your drug product manufacturing. As a manufacturer, you…
3Process validation
Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Lack of Process Validation You failed to provide data to demonstrate you have validated the manufacturing processes for all your drug products. During the inspection, when asked for validation documents for your…
4Equipment and facility
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)). 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) . This product is labeled as “Caution: Keep away from…
5Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). You have inadequate laboratory controls. For example: • You failed to demonstrate your water…
