Posts Tagged deficiencies

FDA warns Hospira about deficiencies in medical devices – Health …

Thursday, May 16th, 2013 | Permalink

The May 9 letter describes a dozen deficiencies in design and quality assurance processes for medical devices that FDA officials found during an inspection at the company's headquarters in Lake Forest. The warning letter is …

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FDA warns Hospira about deficiencies in medical devices – Health …

Alexza rockets on re-submission of Adasuve NDA – Pharmaceutical …

Monday, June 25th, 2012 | Permalink

Alexza has stated that it believed the deficiencies were medical device specific and readily addressable. Since the receipt of the CRL, Alexza has received further clarification of the specific deficiencies from the FDA and has …

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Alexza rockets on re-submission of Adasuve NDA – Pharmaceutical …