FDA Warns Five Medical Device, Three Pharma Companies

Regulatory NewsRegulatory News | 31 January 2017 |  By 

The US Food and Drug Administration (FDA) on Tuesday released warning letters for five medical device companies and three pharmaceutical firms located in India, China, Canada, Korea, Germany and Italy – further revealing the depth of the agency’s international work.

On the pharmaceuticals side, FDA warned Milan, Italy-based Facta Farmaceutici following a January 2016 inspection that uncovered original data showing failed results for multiple sterile drug products, but data the company reported showed passing results.

For Gujarat, India-based CTX Life Sciences, FDA investigators “observed rust, insects, damaged interiors, and/or drug residues” in pieces of manufacturing equipment.

In addition, FDA investigators inspecting Cixi City, China-based Ningbo Zhixin Bird Clean-Care Product Company last May found the company’s Quality Control Unit (QCU) failed to review and approve drug product production and control records.

On the medical device side, FDA warned Korea-based Shina Corporation as the company failed to establish and maintain procedures for implementing corrective and preventive actions (CAPAs) after receiving complaints of white sticky residue on gaskets, finding a broken syringe and as one of the company’s CAPA forms does not require that information related to quality problems is disseminated to those directly responsible for assuring the quality of such products.

Canada’s Savaria Concord Lifts, which manufactures lifts and wheelchair accessible vans, was warned by FDA for problems related to its CAPAs and its failure to identify requirements for CAPA procedures.

CAPAs were also a problem for Korean-based Incyto, which FDA’s review revealed a lack of details about the investigations conducted and effectiveness checks conducted.

FDA warned Montreal-based Ropack for failing to validate its artificial saliva manufacturing process, in addition to other problems.

And Berlin-based Biotronik also received a warning letter dated September 2016 following an inspection from last March that found, among other things, that the “process used to manufacture the coated Selectra Catheter lead introducer system lacked statistical rationale.”

Savaria Concord Lifts, Inc. 8/3/16

Ropack, Inc. 8/3/16

Shina Corporation 8/23/16

Biotronik SE & Co. KG 9/1/16

INCYTO CO., LTD. 9/8/16

Cixi Zhixin Bird Clean-Care Product Co., Ltd. 1/6/17

FACTA Farmaceutici S.p.A. 1/13/17

CTX Lifesciences Private Ltd. 1/18/17


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