<span class="archive__title-prefix>Posts Categorized:</span> Blog

During a March 2024 inspection of a finished drug company in China, FDA investigators Brandy N Lepage and Karen A Briggs encountered company management that limited access to manufacturing areas, disallowed photography, and supplied fewer documents than requested, many of them heavily redacted. For example, requested batch records for an over-the-counter (OTC) drug product […]

Recent FDA inspection data paints a clear picture: deficiencies in Corrective and Preventive Action (CAPA) systems remain among the top reasons medical device sites receive citations and warning letters. We analyzed Redica Systems data and found that out of 72 inspected sites that had received warning letters between 2020 – 2024, 59 (82%) had been […]

A 510(k) submission is an FDA premarket notification proving that a new or modified Class II medical device is as safe and effective as a legally marketed predicate. The file must demonstrate substantial equivalence, contain full device description, labeling and test data, and—since 2024—is expected to follow the eSTAR template. Reviewers place submissions on hold […]

A 503B outsourcing facility compounds sterile drugs in bulk under Section 503B of the FD&C Act. It must register with FDA, follow current Good Manufacturing Practice (CGMP) and undergo routine inspections. Common deficiencies include inadequate sterility assurance, poor documentation and environmental-monitoring gaps that trigger Form 483s or Warning Letters. Table of Contents What is a 503B outsourcing […]

FDA inspections of biologic manufacturing facilities are identifying deficiencies that include potential microbiological contamination in aseptic processing along with data integrity and process control and variability concerns. FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Office of Pharmaceutical Manufacturing Assessment (OPMA) Senior Pharmaceutical Quality Assessor Dr. Madu Dharmasena provided manufacturing […]

Overview: What is MHRA UK? The Medicines and Healthcare Products Regulatory Agency (MHRA) serves as the regulatory body overseeing the safety, quality, and efficacy of pharmaceuticals and medical devices within the United Kingdom. Established to protect and promote public health, the MHRA ensures that all medical products available in the UK market meet stringent regulatory […]

Being well-prepared for FDA inspections is essential for maintaining product quality, regulatory compliance, and avoiding serious business setbacks. FDA inspections are critical events that can shape a company’s market access and reputation. Redica Systems offers the most comprehensive database of FDA inspection documents, which also powers our Quality and Regulatory Intelligence (QRI) platform. This FDA […]

Could Granules be facing similar enforcement actions as Intas including an Official Action Indicated (OAI) inspection classification or a warning letter? Recent FDA inspection findings for Granules finished dosage form facility in Gagillapur, India, are strikingly similar to those found during a 2022 FDA inspection of Intas Pharmaceuticals, another large drug manufacturer located in India. […]

A review of the 2024 MedTech device-related adverse events and product issues for 2024 as revealed by FDA’s MAUDE (Manufacturer and User Facility Device Experience) database and analyzed using Redica Systems reports shows events and trends worth highlighting, in particular for integrated continuous glucose monitoring (iCGM) systems and CPAP machines. First a few caveats. Reports […]

In 2011, drug shortages captivated the United States’ attention as an emerging public health crisis, as the number of reported shortages tripled between 2005 and 2011.1 With this alarming data, the Obama Administration took action to protect the public against worsening drug shortage conditions. On 31 Oct 2011, Executive Order 13588 – Reducing Prescription Drug […]