Van Zyl GMP International. Dr AJ van Zyl

07/04/2026

https://theconversation.com/massive-eye-drop-recall-reflects-ongoing-issues-with-manufacturing-and-fda-inspection-279971

The recall potentially affects more than 1 million people. It is the second time the FDA has found sterility issues at the company in three years.

31/03/2026

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-magnesium-sulfate-water-injection-usp?utm_medium=email&utm_source=govdelivery

Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride I

24/03/2026

Summary from Pathwise

"Key FDA 483 Findings in 2025: Investigations

FY2025, show that inadequate investigations remain one of the most persistent bottlenecks and top observations.

Top 483 Categories: Inadequate investigations, ineffective CAPA implementation, and data integrity concerns remained at the top of the list in 2025.

Rising Observations: 483 observations for Drugs rose from 561 in 2024 to 713 in 2025, while Device observations rose from 672 to 791.
Persistent Failure: In 2025, the FDA found that many companies continue to fail to conduct thorough, deep root-cause investigations, treating deviations as clerical closures rather than learning opportunities.
Warning Letter Drivers: Inadequate investigations of non-conformities and missing documentation are frequently Cited in 2025 warning letters".

24/03/2026

150th Assessment session of WHO PQ

23/03/2026

Class 2 Medicines Recall: Regent Medical Limited / Mölnlycke Health Care, Hibiwash 500ml, EL(26)A/15

Mölnlycke Health Care are recalling specific batches of Hibiwash due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring. The microbial contamination has been identified as Burkholderia cepacia. The investigation is ongoing, and to date no Hibiwash products have been found to be contaminated, however the batches at risk of contamination are being recalled as a precaution to mitigate any risks to public health.

Burkolderia cepacia is a gram-negative bacteria that is widely found in the environment, including soil and water, and has intrinsic resistance to many antibiotics. The risk to the general public from Burkholderia cepacia is considered very low, but some patient groups (such as individuals with cystic fibrosis or awaiting lung transplant) are at potentially increased risk of developing infections.

The use of the batches specified in this notification should be avoided. There have currently been no confirmed cases of Burkholderia cepacia infection in patients from the affected batches.

This product is also typically provided to patients pre-surgery for decolonisation and prevention of Staphylococcus aureus skin and soft tissue infections, and can be used for pre-operative surgical hand disinfection.

22/03/2026

Summary of Warning Letter

09/03/2026

https://www.thehindu.com/business/Industry/cipla-recalls-over-400-cartons-of-cancer-drug-in-us-usfda/article70718246.ece

Cipla recalls over 400 cartons of Nilotinib cancer medication in the U.S. due to manufacturing specification issues, USFDA reports.

02/03/2026

13/02/2026

Interesting article

The Competition Commission is investigating several pharmaceutical manufacturers after a complaint from the health department.

12/02/2026

Memories... 2016

14/01/2026