ECA新聞：公司因運輸操作不良被記為缺陷

06.02.2018

Company cited by FDAfor poor Transportation Practice公司因運輸操作不良被記為缺陷

An Indian site of the pharmaceutical company Glenmark wasinspected by the FDA in November 2017. The FDA now published the form 483*including observations related to bad shipping practice. Data shows that acream intended for the U.S. market was exposed for more than 30 hours to up to44.5°C. That alone is bad enough - but the company didn"t conduct aninvestigation "todetermine the impact … on the quality and integrity of the product".That is even more interesting as the company had received 21 consumercomplaints within two years saying that the cream in question was"watery".

FDA於2017年11月檢查了GLENMARK在印度工廠。FDA現在發布了483表，其中有與不良運輸操作有關的缺陷。數據顯示銷往美國市場的膏劑暴露於高達44.5°C環境中超過30小時。僅此就已夠差的了—而公司還沒進行調查「以確定其對藥品質量和完整性的影響」。這可比偏差本身更有意思，因為公司已經在2年內收到了21份消費者投訴說該膏劑「有很多水」。

*483 is the number of a form used by an FDA Investigatorto document the deficiencies he found during an inspection. It is issued at theend of the inspection and should be answered officially. This response isexpected within 15 working days after its issuance. Only then it is guaranteedthat the statement will be taken into account in a possible Warning Letter.

483是FDA調查人員用於記錄檢查期間所發現缺陷的表格編號。它會在檢查結束時簽發，並要正式回復。該回復要在簽發後15個工作日內發出。只有那時才能保證在可能的警告信中考慮該申明。

Source:FDA483 Form

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