FDA Enforcement News

18 05, 2018

Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-18T13:12:09+00:00 May 18th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April [...]

15 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

By | 2018-05-15T14:40:04+00:00 May 15th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this week Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA published Among this later collection are the MHRA GCP Inspection Metrics Changes in the [...]

11 05, 2018

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-11T14:58:07+00:00 May 11th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices. [...]

8 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/29/18

By | 2018-05-08T13:19:00+00:00 May 8th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA 4 from EMA 2 from Health Canada 2 items from Pakistan FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important. To see the complete list of laws, [...]

4 05, 2018

Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-05-04T12:55:48+00:00 May 4th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them 1 warning letter went to an API manufacturer 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the outcome of [...]

1 05, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/22/18

By | 2018-05-01T15:45:51+00:00 May 1st, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Guidance documents are available from the FDA and EMA this week across a variety of topics.  Lots to read there from both the FDA and EMA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. Enforcement publications were busy this week: 3 drug warning letters from [...]

27 04, 2018

Week of Apr 15th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-04-27T15:18:49+00:00 April 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

Maybe back to more normal with 16 warning letters posted this week: The Center for Tobacco Products issued 9 warning letters 3 were issued to manufacturers of finished pharmaceuticals (all are OTC manufacturers located outside the US) 2 were issued to compounding pharmacies So far in CY2018, 14 warning letters out of a total of 33 drug GMP warning [...]

25 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/15/18

By | 2018-05-08T12:54:13+00:00 April 25th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers FDA published several new guidance, both draft and final, this week: 2 are administrative 2 address quality 1 addresses format for submission of vaccines data Bonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7. TGA published 2 [...]

16 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 4/8/18

By | 2018-04-24T15:40:43+00:00 April 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week for guidance: The FDA published 6 documents. Nothing from EMA in the areas we follow. WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance. Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA. [...]