PIC/S published Recommendation PI 058-1, titled “Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022).” The document was prepared by experts from…
FDA describes how it evaluates pharmaceutical manufacturers through risk-based surveillance inspections and for-cause inspections. Observations may be documented on Form FDA 483, which does not represent a final agency determination;…
FDA describes GDUFA III facility-related commitments, including inspection transparency, communication of inspection information, and support for foreign regulators. For qualifying U.S.-based establishments included in foreign marketing applications, FDA will, upon…
FDA’s CDER describes initiatives intended to encourage manufacturing innovation and reliable production of high-quality drugs. The Emerging Technology Program offers early engagement and recommendations for companies developing advanced manufacturing technologies,…
The FDA CDER FOIA Electronic Reading Room page lists frequently requested or proactively posted compliance records for drugs. Its table identifies untitled letters and other correspondence by record date, FEI number where shown, firm, record type, country, and posting date. Listed firms include Neeyaan, Formulated Solutions, Port Jervis Laboratories, Chemspec Chemicals, Aptar Radolfzell, Amazon.com, Industria Farmaceutica Nova Argentia, Laurus Synthesis, Nectar Lifesciences, Shandong Boyuan Pharmaceutical, Silliker/Merieux NutriSciences, and Valisure. The page also directs users to FDA databases for inspections, drug-promotion untitled letters, Forms FDA 483, and establishment inspection reports. Content is marked current as of August 18, 2026.
FDA issued a closeout letter to NeilMed Pharmaceuticals Inc., referencing FEI 3002998723 and drug products, after evaluating the firm’s corrective actions responding to a Warning Letter dated May 26, 2023. FDA stated that the firm appears to have addressed the violations cited in that Warning Letter. The agency noted that future inspections and regulatory activities will further assess the adequacy and sustainability of the corrections. FDA also emphasized that the closeout letter does not remove the firm’s responsibility to sustain compliance with the Federal Food, Drug, and Cosmetic Act, implementing regulations, and other relevant legal authority, and does not preclude future regulatory action if violations are later observed.
FDA states that its review of records submitted by TSP Solutions identified significant CGMP violations involving sunscreen drug products. The firm did not demonstrate adequate finished-product testing before release. Submitted certificates of analysis and batch records lacked appropriate assays for active ingredient content, impurity testing, and appropriate microbiological testing. FDA also found that the firm did not demonstrate adequate identity testing of incoming components and accepted supplier certificates of analysis without verifying test results at appropriate intervals. Component quality verification consisted only of reviewing supplier certificates and material safety data sheets. In addition, FDA stated that the firm had not established an adequate quality unit with sufficient responsibilities and authority to oversee drug manufacturing. The quality unit failed to ensure adequate production and process control procedures, qualification of manufacturing equipment, laboratory control procedures, and an adequate ongoing stability program. FDA recommended a qualified CGMP consultant and a comprehensive six-system audit. The firm’s drugs were placed on Import Alert 66-40 on August 14, 2026.
FDA’s records review of Sanrace Biotechnology found significant CGMP violations involving component testing, process control, and quality-unit oversight for OTC drug manufacturing. FDA states the firm did not demonstrate adequate identity testing of incoming components, including an active ingredient, and did not perform the USP identification test capable of detecting specified hazardous impurities on each shipment of each lot. FDA said this left the firm without scientific evidence that components met appropriate specifications before use. The firm’s response also stated that it had no process validation procedures or studies, so it did not demonstrate reproducible, controlled manufacturing yielding uniform quality. FDA further found that the quality unit was not established with adequate responsibility and authority over manufacturing. Cited examples included inadequate laboratory control procedures, an inadequate system monitoring program with insufficient attribute testing, and an inadequate ongoing stability program. Submitted records lacked complete stability data and testing for viscosity, pH, assay, and microbiological attributes throughout shelf life. FDA placed the firm’s drugs on Import Alert 66-40.
FDA’s Compounding Quality Center of Excellence describes two discussion series for outsourcing facilities to share issues, practices and solutions intended to improve compounded drug quality. The New Outsourcing Facility Discussion Series is aimed at newly registered facilities and includes an “Automation Basics” session on November 18, covering automation types, potential efficiency and quality benefits, and implementation challenges. The Quality Discussion Series focuses on quality culture, best practices and current good manufacturing practice requirements. Its January 12, 2027 session addresses integrating automated systems for quality outcomes, including change management, quality considerations and maintaining CGMP requirements while pursuing efficiencies. The page is current as of October 21, 2026.
EMA updated its GMP/GDP Q&A on 21 October 2026 concerning batch numbers on medicinal products relabelled or repacked for parallel trade. The Q&A states that applicable national legislation or guidance should be followed. Where none exists, the outer packaging should carry one batch number allocated by the parallel trader, ideally combining the original batch number with a unique repackaging or relabelling code. Traceability between original and additional numbers must be documented. If separate numbers are used, both must appear in recall information. A completely different parallel-trader batch number is strongly discouraged and requires justification and supervisory-authority authorisation.