Warning letters, 483s, Recalls, Import Alerts, Audit observations
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Popular: Warning Letters, Recalls
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence – for GxP computerised systems which interface with Artificial Intelligence models to predict or classify data with direct impact on patient safety, quality and data integrity. For...
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted for Medical devices by third Party testing facilities. As per the notification...
Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….
List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.
Popular: Warning Letters, Recalls
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence – for GxP computerised systems which interface with Artificial Intelligence models to predict or classify data with direct impact on patient safety, quality and data integrity. For...
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted for Medical devices by third Party testing facilities. As per the notification...

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing deficiencies in cleaning and cleaning

Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA Investigators Arsen Karapetyan and Wayne D Mcgrath in

Jubilant Generics Roorkee facility was inspected in January 2024 by USFDA investigators Jeffrey P.Raimondi and Tamil Arasu. The inspection revealed lapses in
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Popular: Warning Letters, Recalls
The European Commission (EC) has published a draft guidance – Annexure 22 – Artificial Intelligence – for GxP computerised systems which interface with Artificial Intelligence models to predict or classify data with direct impact on patient safety, quality and data integrity. For...
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted for Medical devices by third Party testing facilities. As per the notification...
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...