“Real Breaking News!” India’s leading cGMP offender has now imported their deviant behaviors to its sterile products USA facility! Wochardt has been the subject of huge recalls and import bans by FDA over non-compliance of cGMPs, and now the FDA is apparently quite upset that Wochardt is not adhering to its stated commitments for remediation.
As background, a January 2016 report in Fierce Pharma regarding FDA Form 483 Inspection Report identified 9 serious cGMP violations at Wochardt’s “state-of-the art” sterile injectables facility in Shendra, Aurangabad, India. Now just a year later, we learn Wockardt is again reeling (or otherwise) with a totally different and scathing FDA Warning Letter for its Morton Grove Pharmaceuticals’ sterile products facility in Illinois. One wonders why and how transcontinental deviant cGMP practices and violations are so freely crossing borders now, even flowing INTO American manufacturing sites under the control of foreign owners! Maybe we need a stronger and taller wall of compliance at the border!
As usual, the FDA heavily redacted the names of involved drug products and drug substances. Still we wonder WHY. But FDA left a few hints on these very widely distributed prescription products: triamcinolone acetonide lotion and fluticasone propionate nasal spray. If these drugs are currently in your medicine cabinet, you would do well to read on and see the FDA Warning Letter.
The litany of FDA’s observations of cGMP violations at Wochardt’s Morton Grove site included:
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed,
- failure to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards,
- failure to follow written procedures applicable to the quality control unit,
- failure to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product,
- the quality control unit failed to test in-process materials during the production process,
- failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records
FDA then just started to get upset: The Agency blasted Wochardt/Morton Grove over lack of responsive actions for repeated cGMP violations and deviations at 5 other Wockhardt facilities since 2013. Finally the U.S. FDA hammered home the crucial passage of this steaming Warning Letter:
“At this time, seven Wockhardt facilities (including Morton Grove) are considered out of compliance with CGMP. These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs.
In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist.
Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.”
So… What’s in YOUR Medicine Cabinet?? Deficient, non-compliant Wochardt prescription products?
Now you can act on similar flagrant cGMP deviations and violations!
IF YOU OR YOUR COLLEAGUES, anywhere in the world, have evidence of significant cGMP deviations in the last 6 years for American-bound (OR AMERICAN MADE) DS or DP, contact us confidentially by emailing us at: [hidden email] ….or call us in the US on +001-202-780-9957. We help match would-be whistleblowers with CM&C experts and qualified lawyers to ensure they receive the highest awards possible and protection from retaliation. There is no fee for our services. The Pharmaceutical Integrity Coalition (PIC) is an independent Advocacy Group, with no ties to the Pharma industry
The U.S. Department of Justice is authorized to pay whistleblowers – pharma workers and executives with inside knowledge of cGMP violations – an award of up to 30% of whatever the government collects from wrongdoers. We know that most pharma employees are hard-working, conscientious people that truly care about the industry and patient safety. We also know that receiving a large cash award potentially in the tens of millions of dollars is necessary to help those workers who do come forward to get a fresh start.
Our goals are simple: stop contaminated and questionable potency pharmaceuticals from entering the US commerce stream and reaching patients, and restore integrity to our profession and industry. We want to precipitate “the beginning of the end” of cGMP violations from manufacturing of America’s Pharmaceutical products anywhere in the world, and move to a future of sustained dependability and full trust in pharmaceuticals for health and healing. It’s all about why and how we grew our careers in the Pharma industry, to help people, and the only way we know how to practice our CM&C craft.
The Feb. 17, 2017 FDA Warning Letter FDA sent to Wochardt’s Morton Grove IL facility leader Sunil Khera is found here: www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545133.htm
Please read the original Fierce Pharma article on Wochhardt and Morton Grove Pharmaceuticals.