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/Michael de la Torre

About Michael de la Torre

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So far Michael de la Torre has created 19 blog entries.
9 02, 2018

The Ultimate Guide to Researching Your FDA Inspector

By | 2018-02-16T13:24:46+00:00 February 9th, 2018|Biopharma / Pharma, CGMP, FDA, FDA Enforcement Trends, FDA Inspections, FDA-Regulated Industry, FDAzilla, Food, FSMA, Inspection - Features, Medical Devices, Pharma - Featured|

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list.  And while you know you should set up a complete FDA inspection preparedness program, you just [...]

1 02, 2018

FDA Sent These 15 Warning Letters for Pharma Companies | December 2017

By | 2018-02-01T16:35:03+00:00 February 1st, 2018|FDAzilla|

We took a snapshot of the 15 warning letters (yes, 15) the FDA sent to pharmaceutical companies in December.  Drug manufacturing violations ranged from failing to establish and follow adequate written procedures to failing to reveal consequences that could result from the use of a drug. From pharmaceuticals in San Diego, Korea, and more, here they are (starting with the [...]

31 01, 2018

FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

By | 2018-02-16T13:02:40+00:00 January 31st, 2018|CGMP, FDA Enforcement Trends, FDA Warning Letters, Medical Device - Featured, Medical Devices|

We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter.  Device manufacturing violations ranged from failing to evaluate complaints to failing to establish procedures for quality audits. From device manufacturers in India, Lithuania, and more, here they are (starting with the most recent): […]

15 12, 2017

FDA Sent These 3 Warning Letters for Pharma Companies | November 2017

By | 2018-01-26T23:04:13+00:00 December 15th, 2017|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Warning Letters, FDAzilla|

We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained. From pharmaceuticals in China and India only, here they are (starting with the most recent): […]

16 11, 2017

FDA Sent These 6 Warning Letters for Pharma Companies | October 2017

By | 2018-01-26T23:06:27+00:00 November 16th, 2017|Biopharma / Pharma, FDA, FDA Warning Letters, FDAzilla|

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate. From pharmaceuticals in Wisconsin, India, and more, here they are (starting with the most recent): […]