FDA-Regulated Industry

/FDA-Regulated Industry
6 04, 2018

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

By | 2018-04-06T12:25:29+00:00 April 6th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 8 warning letters this week, including: 1 API manufacturer 1 finished dosage form manufacturer 2 compounding pharmacies DRUGS Keshiva Organics Pvt. Ltd (Maharashtra, India) received a warning letter dated March 15th 2018 based on the outcome of an inspection ending May 31st 2017. The firm is an API manufacturer. FDA identifies that inspections in 2011 and 2014 [...]

5 04, 2018

FDA Office of Product Quality | Annual Report 2017

By | 2018-04-05T15:50:13+00:00 April 5th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

A previous blog entry addressed the Office of Pharmaceutical Quality ‘One Quality Voice’ effort, an aspirational view of FDA’s efforts to ensure coordination in the review, inspection, and approval process as well as post-approval oversight of both facilities and products. Shortly after that publication, FDA’s Office of Product Quality published their first annual report that we address in this [...]

4 04, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/25/18

By | 2018-04-10T13:22:07+00:00 April 4th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

Laws, Regulations, Guidance, and Concept Papers A slow week for guidance publication:  2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. [...]

3 04, 2018

The 8 Best Articles for FSMA Preparation

By | 2018-04-03T12:36:11+00:00 April 3rd, 2018|cGMP Quality Assurance and FDA 483s, Food, FSMA|

FSMA compliance takes a lot of work and determining exactly what food processors, growers, importers, or others in the industry should be doing is something that experts have been writing about. Some articles are purely informational while others provide definitive steps forward. We’ve compiled 8 of the best below: 1. FSMA in a Nutshell In the whirlwind of details [...]

2 04, 2018

Deep Dive into FSMA Foreign Supplier Verification: 5 Pitfalls to Avoid

By | 2018-04-02T16:54:09+00:00 April 2nd, 2018|cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, Food, FSMA|

FSMA (which was signed into law in 2011) laid out many new demands for food processors in the United States. One aspect of FSMA was shifting the responsibility of food safety onto importers by requiring a Foreign Supplier Verification Program (FSVP) to monitor all foreign suppliers. With this complex system in place, it is important to avoid the pitfalls [...]

30 03, 2018

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

By | 2018-04-04T16:46:03+00:00 March 30th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

FDA posted 7 warning letters this week. Among those we cover: 1 to an API firm 2 to finish pharmaceutical manufacturers 1 to a device manufacturer We cover these below. The warning letters issued to drug firms all have significant requirements associated with them that firms are to address. We include these requirements because they provide a roadmap of [...]

29 03, 2018

FDA Sent These 6 Warning Letters for Food Companies | March 2018

By | 2018-03-29T16:36:35+00:00 March 29th, 2018|FDA Warning Letters, FDAzilla, Food|

We took a snapshot of the 6 warning letters the FDA sent to food companies this month. Food violations ranged from failing to wear beard covers to failing to exclude pests from food plants. From companies in Seattle, New York, and more, here they are: A.C. Calderoni & Co., Brisbane, CA - 3 violations: Firm failed to have a [...]

28 03, 2018

The FDA’s “One Quality Voice”

By | 2018-03-28T13:46:24+00:00 March 28th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla|

FDA’s report on pharmaceutical quality for the 21st Century in 2004 put forth their vision for reorganization within the FDA that would strengthen their ability to ensure drug quality. As part of FDA’s reinvention and modernization, they created the Office of Product Quality ‘to promote “One Quality Voice” through the integration of review, inspection, surveillance, policy, and research for [...]

27 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/18/18

By | 2018-04-10T13:28:55+00:00 March 27th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers We have another slow week in the publication of guidance: FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compounding EMA published 1 item addressing pharmacogenomic practices CDSCO (India) and TGA each published 1 We see the usual collection of non-guidance items from MHRA, EMA, FDA, and [...]