Consent decree stops Downing Labs

With a little help from the Department of Justice, FDA has finally been able to stop Dallas-compounder Downing Labs, previously known as NuVision, from manufacturing adulterated drugs.

At FDA’s request, a US District Court judge on Jan. 8 entered into a consent decree for permanent injunction against Downing Labs to prevent the company’s co-owners Ashley Michelle Downing and Christopher Van Downing, and the pharmacist in charge, Roger Mansfield, from distributing drugs made under insanitary conditions and in violation of GMPs.

For almost three years, NuVision has rebuffed FDA’s attempts to bring its manufacturing standards up to par. In 2013 the company refused FDA’s requests to recall its products. FDA subsequently warned health care providers and consumers against their use [A#08130926005]).

In the consent decree, the compounder has agreed to take steps to improve its operations before resuming production.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said that “despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk.”

In the FDA complaint that was filed along with the consent decree, the agency said that “Downing Labs and its immediate predecessor company, NuVision Pharmacy Inc., have a long history of manufacturing drug products under conditions that fall short of the minimum requirements to ensure safety and quality.”

During its most recent inspection from September to October 2015, FDA observed numerous insanitary conditions at the plant. Testing results obtained from Downing Labs identified seven lots of aseptically filled injectable drug products that were filled with microorganisms.

The complaint said that “these microorganisms, if introduced into the body, can cause septic shock, pneumonia and urinary tract infections.”

Zhejiang Hisun gets warning letter

FDA Jan. 12 posted a warning letter it sent Dec. 31 to Zhejiang Hisun Pharmaceutical Co., Ltd., in Taizhou City in China’s Zhejiang Province describing numerous data integrity issues identified during a March 2015 inspection of the site, which has been under import alert since Sept. 9 Also see "Enforcement Updates in Brief" - Pink Sheet, 25 September, 2015..

Many of the issues raised in the warning letter revolved around deletion of data for assay, impurities and other testing of active pharmaceutical ingredients.

FDA was particularly concerned about this, the agency said, because of a “significant number of customer complaints for subpotency and out-of-specification (OOS) impurity levels from 2012-2014.”

Also concerning was this: “During the inspection, an analyst removed a USB thumb drive from a computer controlling an HPLC. When asked to provide the drive, the analyst instead exited the room with the thumb drive. After approximately 15 minutes, management provided our investigator with what they asserted was the USB thumb drive in question. It is impossible to know whether management provided the same USB thumb drive that the analyst had removed.”

Pfizer had formed a joint venture with Zhejiang Hisun in February 2012 ([A#28120221007]).

“The joint venture will provide our patients with high-quality and low-cost branded generic medicines through our internationally compatible management systems and R&D and production technology,” Hisun President Bai Hua said at a September 2012 launch ceremony attended by, among others, Pfizer CEO Ian Read ([A#28120913007]).

FDA drops alert due to chemo shortage

FDA Feb. 18 excluded an active pharmaceutical ingredient from a Sept. 9, 2015, drug GMP import alert Also see "Enforcement Updates in Brief" - Pink Sheet, 25 September, 2015. because there is a critical shortage in the US of the API, daunorubicin hydrochloride for liposomal application, which is a chemotherapy treatment for AIDS-related Kaposi's sarcoma as well as for leukemia and non-Hodgkin lymphoma.

FDA had raised several data integrity concerns in a Dec. 31, 2015, warning letter to the company, Zhejiang Hisun Pharmaceutical Co. Ltd. of Taizhou City, China.

Ipca hit with warning letter

FDA Feb. 9 posted a warning letter it sent Jan. 29 to Ipca Laboratories Ltd., Mumbai, India, that focused on data integrity concerns identified during a series of inspections last year at three sites in central India’s state of Madhya Pradesh.

There was an inspection in July at an active pharmaceutical ingredient facility in Ratlam, another in October at a drug product site in Pithampur, and a third in December at a drug product site in Silvassa.

The Pithampur and Silvassa sites have been under import alert since March 24, 2015, the Ratlam site since Jan. 22, 2015.

Chan Yat Hing’s cosmetics ploy blocked

FDA Jan. 7 expanded a Dec. 3 alert suspending drug imports over GMP failures at Chan Yat Hing Medicine Factory in Hong Kong to include cosmetics imports after determining that the company was declaring drugs as cosmetics ([A#08151217003]). FDA also hit the company with a warning letter on Dec. 15.

Recent FDA import alerts

FDA recently suspended drug imports from two Chinese manufacturers due to drug GMP issues:

Tianjin Zhongan Pharmaceutical Co., Ltd., in Tianjin, China’s Xiqing District, on Feb. 11.
Zhejiang Hisoar Pharmaceutical Co. Ltd., in Taizhou City, located in China’s Zhejiang Province, on Jan. 20.

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