The US Food and Drug Administration (FDA) has updated two Compliance Program Guides (CPGs) on GMP inspections. One for pre-approval inspections (PAI) and one for routine surveillance inspections.
FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.
How to react to Deficiencies after an FDA Inspection?
GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?
FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers
The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.
FDA Warning Letter: Lab Data Integrity disregarded
In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022. The Warning Letter mentions the list of cGMP observations for Active Pharmaceutical Ingredients (APIs).
Pharmaceutical Industry: FDA Data on the Level of Quality
The FDA has published a report on the state of drug quality - and the results are mixed. However, if one takes a closer look, the reasons can be quickly identified.
FDA Form 483: Sampling Obviously Documented Incorrectly
The U.S. Food and Drug Administration (FDA) issued a Form 483 to India-based manufacturer Sun Pharmaceutical following an inspection of its Mohali facility in August 2022. Among other observations, it came out that employees responsible for collecting samples did not enter the buildings where the samples were documented to have been collected. In other cases, based on building access records, the employee was in a different building at the time the sample was documented to have been collected.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.
FDA Warning Letter: Testing, Stability Program and Quality Oversight
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an over-the-counter (OTC) drug product manufacturer in Los Angeles. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight. In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.
Refusal to Permit Inspection - What are the Consequences?
Inspections are a regulatory requirement in the GMP environment. This also applies to the USA. But what happens if a manufacturer simply refuses to permit a GMP inspection?
FDA Warning Letter: No Stability Studies for Reworked Batches
In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.
The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.