FDA Warning Letters

16 03, 2018

Week of Mar 4th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-03-16T16:03:32+00:00 March 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspections, FDA Warning Letters, FDAzilla|

FDA posted six new warning letters this week including one to a compounding pharmacy and two to finished drug manufacturers. Both finished drug manufacturers are located outside the US. We address those below. Finished Drug Manufacturers: Zhejiang Ludao Technology Co., Ltd (Taizhou, China) received a warning letter on February 23th 2018 based on the outcome of an inspection ending [...]

12 03, 2018

[UPDATED] Interval Between Inspection and Warning Letters Decreasing

By | 2018-03-12T12:55:54+00:00 March 12th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Form FDA 483|

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013. The relevant table and graph is provided below. We’ve been watching this trend for the past couple of years, and now we are seeing the reverse—the interval [...]

9 03, 2018

Week of Feb 25th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-03-09T16:04:04+00:00 March 9th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla|

Among the eleven warning letters posted this week are three of interest. One was issued to an API manufacturer and two were issued to finished drug product manufacturers. All three firms are located outside the US. Pharmaceuticals Alchymars ICM SM Private Limited (Chennai, India) received a warning letter on February 16th 2018 based on the outcome of an inspection [...]

2 03, 2018

Week of Feb 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-03-06T12:40:26+00:00 March 2nd, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla, Medical Devices|

A collection of warning letters were issued from the Center for Tobacco Products this week. In FY2017, the center issued 97% of all warning letters issued by the FDA. Also, the FDA issued one warning letter to a finished drug manufacturer and one to a device manufacturer. Both warning letters were issued to sites outside the US. We cover [...]

27 02, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/18/18

By | 2018-02-27T12:14:29+00:00 February 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front. To see the complete list of laws, regulations, guidance, and concept papers published this week, [...]

23 02, 2018

Week of Feb 11th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-02-26T10:16:20+00:00 February 23rd, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla|

The FDA posted 6 warning letters this week, and we cover 5 of them below. One went to a device firm, and 4 went to finished pharmaceuticals sites, all located outside the US. Medical Devices Curasan AG (Frankfurt Germany) site received a warning letter on August 23, 2017, based on the outcome of an inspection ending May 11, 2017. The [...]

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 [...]

16 02, 2018

Week of Feb 4th 2018 | FDA Sent These Warning Letters for Pharma Companies

By | 2018-02-19T09:41:49+00:00 February 16th, 2018|Biopharma / Pharma, CGMP, FDA Warning Letters, FDAzilla|

The FDA published only seven warning letters this week. Of interest to us are two issued to finished drug manufacturers. The FDA continues their focus on OTC facilities that seemed to begin in 2017. Polaroisin International Co., Ltd. (Taiwan) received a warning letter on January 25, 2018, based on the outcome of an inspection ending September 15, 2017. FDA placed [...]

7 02, 2018

20,000 FDA Warning Letters

By | 2018-02-08T14:16:28+00:00 February 7th, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|

Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database.  As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month).  Yes it’s true:  arguably, the older the warning letter, the [...]