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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 12 blog entries.
22 02, 2018

5 Ways Manufacturing Quality Problems Can Take Down a Company

By | 2018-02-22T17:26:09+00:00 February 22nd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDA-Regulated Industry, Food, Form FDA 483, Medical Devices|

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights into any potential issues that may be brewing. Almost all quality-related warning letters start with an inspection and a 483. While some warning letters result [...]

9 02, 2018

FSMA Has Arrived – Here’s What We Know So Far

By | 2018-02-16T11:04:39+00:00 February 9th, 2018|FDAzilla, FOOD - Featured, MOST POPULAR|

Since the introduction of FSMA in 2011, the FDA issued new guidance to the Food Industry for GMP and HARPC (Hazard Analysis and Risk-Based Preventive Controls). This guidance was encapsulated in 21 CFR 117, which is slated to replace 21 CFR 110. The biggest difference in 21 CFR 110 and 21 CFR 117 is that [...]

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 [...]

5 02, 2018

FDA Sent These 16 Warning Letters for Pharma Companies | January 2018

By | 2018-02-05T16:39:23+00:00 February 5th, 2018|FDAzilla|

We took a snapshot of the 16 warning letters the FDA sent to pharmaceutical companies last month.  The “Violation of the Month” was failing to bear adequate directions for the drug’s intended use. From pharmaceuticals in New Jersey, Japan, and more, here they are (starting with the most recent): […]

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): […]

29 01, 2018

Last 30 483s Customers Have Purchased – January 2018

By | 2018-01-29T15:33:18+00:00 January 29th, 2018|FDAzilla, Last 30 483s Purchased|

We see a lot of people, all throughout the world, purchasing 483s from our FDA document store.  For example, this month customers came from Ireland, India, and China.  Here are some of the tools of the trade they purchased from us: […]

18 01, 2018

FDA Issued 42 Product Recalls, Import Alerts, and Consent Decrees in December 2017

By | 2018-02-16T22:37:46+00:00 January 18th, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

18 12, 2017

Last 30 483s Customers Have Purchased – December 2017

By | 2018-01-26T23:00:06+00:00 December 18th, 2017|FDAzilla, Last 30 483s Purchased|

We see a lot of people, all throughout the world, purchasing 483s from our FDA document store.  For example, this month customers came from Japan, the United States, China, and Switzerland.  Here are some of the tools of the trade they purchased from us starting with the most recent: […]