cGMP Quality Assurance and FDA 483s

/cGMP Quality Assurance and FDA 483s

See You At ISPE

Govzilla is on the road again! I hope to see you at the International Society for Pharmaceutical Engineering (ISPE) Quality Manufacturing Conference in Arlington, VA from June 4th - 6th. I am excited because this conference will be tackling challenges in quality manufacturing with a special emphasis on the global manufacturing environment. Everyday I speak with our customers from all [...]

By | 2018-05-31T11:57:07+00:00 May 31st, 2018|Biopharma / Pharma, CGMP, FDAzilla|

GMP Regulatory Newsletter: Summary Scan | Week of 5/20/18

Laws, Regulations, Guidance, and Concept Papers: FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011. EMA published 1 on IMPs for consultation. HPRA, WHO, Health Canada, and CDSCO each published 1. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence [...]

FDA Sent These 4 Warning Letters for Food Companies | April 2018

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged from products containing a poisonous or deleterious substance to companies failing to have an HACCP plan. From companies in Washington, Kansas, and more, here they are: Arrow Reliance Inc., Tukwila, Washington – 1 violation: Products are adulterated under section 402(a)(1) [...]

By | 2018-05-29T17:01:12+00:00 May 29th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

Week of May 13th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA published 4 warning letters this week: 2 were issued for unapproved new drugs 2 were issued to drug firms addressed below DRUGS: Ei LLC (Kannapolis, NC) received a warning letter on April 16th 2018 based on the outcome of an inspection ending October 6th 2017. Based on the nature of manufacturing and the identified deficiencies, it is interesting [...]

Part 1: The FDA and MHRA’s Most Recent Drug Inspection Observations

INTRODUCTION A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including: FDA forms-483 Establishment Inspection Reports Warning Letters Recalls Import Alerts Consent Decree Agreements EU Reports of GMDP Noncompliance  This 3-part article series presents recent publications of GMP drug product inspection data from CDER and MHRA: The CDER data are from drug inspections conducted in FY2017 [...]

GMP Regulatory Newsletter: Summary Scan | Week of 5/13/18

Laws, Regulations, Guidance, and Concept Papers A lite week for new guidance publications:  2 each from FDA and EMA. Among the non-guidance publications are 2 of particular interest: 1st is a report of the drug approval times in the major health authority jurisdictions (including some nice graphs and figures) published by The Centre for Innovation in Regulatory Science. The [...]

96 New FDA 483s | May 21st 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

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

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 [...]

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