U.S. Warning Letter caused by Data Integrity Failures
In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023. The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, can be checked here.
PIC/S is a collaboration of regulatory agencies in the field of GMP for human and veterinary medicines. The goal of PIC/S is to provide harmonized standards and training to ensure that one inspection per site will also be recognized by every other authority. The 2022 report provides an overview of PIC/S activities for that year. What does it include?
Series of FDA Warning Letters due to inadequate Testing of Glycerin and Other High-Risk Drug Components
Just recently, we reported on a Warning Letter regarding a manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. The FDA has now published a whole series of Warning Letters that revolve around the same topic.
FDA Warning Letter: Inadequate Investigation of Humidity Excursions
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. During an inspection at an Indian company, the FDA investigators observed several GMP violations concerning inadequate investigation of humidity excursions, data integrity deficiencies, and inadequate testing of component lots used to manufacture the OTC drug products.
Identity Testing of Glycerin in Focus of an FDA Warning Letter
At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.
The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of GMP for medicinal products has entered into force. It applies to both human and veterinary medicinal products.
FDA criticised over inadequate GMP Inspections in India and China
Republican Congress members are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA regulations and express this in a letter to the FDA Commissioner.
FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.
New in the ECA Members Area: "QA Responsibilities" in the Mirror of Warning Letters
The FDA's Warning Letters contain detailed descriptions of GMP deficiencies and thus provide a useful perspective in the context of preparing for an FDA inspection. In the members' area of the ECA Academy website, topic-focused descriptions of these GMP deficiencies are available, e.g. a compilation on GMP violations in the area of quality assurance.
As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.
Turkish Authority publishes new Guideline on GDP Inspections
The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.
FDA now also assesses Countries and Regions as a Risk Factor
The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.
Packaging of Solid Dosage Forms: Warning Letter in the USA
Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.
Appearance as a Release Test? This is not the Way to get through an Inspection
The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.