FDA Warning Letters Week Of 8/23/2020: Sterility Assurance Failures &...
During the week of Aug. 23, the FDA released two warning letters, one to a drug manufacturing site in India and another to a HCT/P facility. The former concerned sterility assurance failures and the...
View ArticleFDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues &...
Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received...
View ArticleFDA Warning Letters Week Of 9/6/2020: Data Integrity Failures & Lack of...
FDA posted two Warning Letters issued to pharma companies for GMP violations last week. One cited data integrity failures among other observations at an OTC manufacturer while the second cited a drug...
View ArticleFDA Warning Letters Week Of 9/13/2020: Unreviewed Batch Records & Lack of...
Last week, FDA posted two warning letters to pharmaceutical firms. One, issued to an OTC manufacturer and API repackager, highlighted product released to market without a batch record. The other,...
View ArticleFDA Warning Letters Week Of 9/20/2020: Quality Unit Failures & Compounding...
Last week, FDA issued Warning Letters to two drug companies, one a repackager and the other a manufacturer of sunscreen, and two compounding pharmacies. The post FDA Warning Letters Week Of 9/20/2020:...
View ArticleFDA Warning Letters Week Of 9/27/2020: Aseptic Process Issues & More...
Last week, FDA issued one Warning Letter to a drug manufacturer and five to compounding pharmacies. The drug manufacturer Warning Letter focused on aseptic processing deficiencies. The post FDA Warning...
View ArticleQ2 2020 Roundup: Warning Letters to Food & Dietary Supplement Firms
The COVID-19 pandemic dominated news headlines in Q2. This naturally seeped into the FDA's food and dietary supplement Warning Letters for the quarter. FDA issued a number of Warning Letters to dietary...
View ArticleFDA Warning Letters Week Of 10/4/2020: Validation Failures & Medical Device...
Last week, FDA issued a Warning Letter to a drug firm and another to a medical device manufacturer. Lack of of process validation and cleaning validation were some of the deficiencies mentioned in the...
View ArticleFDA Warning Letters Week Of 10/11/2020: Unauthorized Cell Therapy &...
Last week, FDA issued an untitled letter to a manufacturer of umbilical cord-derived cell therapy products and a Warning Letter to a sterile manufacturing site in India. The post FDA Warning Letters...
View ArticleUpcoming Webinar | Comparing and Analyzing Russian, UK, and US Top Ten Pharma...
On Thursday, Oct. 29, join us at 1:30 p.m. EST for a webinar featuring Govzilla Senior GMP Quality Expert Jerry Chapman. His presentation, "Comparing and Analyzing Russian, UK, and US Top Ten Pharma...
View ArticleFDA Warning Letters Week Of 10/18/2020: Misbranded Biologics & Pharmacy...
API issues served as a highlight for one of two Warning Letters issued last week. That one was issued to a drug product manufacturer following a March inspection. The second Warning Letter was sent to...
View ArticleAn Update on 503B Compounding
Read a summary of the Govzilla July 30 webinar on the current state of 503B outsourcing facilities, including a look at regulatory developments. The post An Update on 503B Compounding appeared first on...
View ArticleFDA Warning Letters Week Of 10/25/2020: Cleaning Validation & Foreign Particles
Last week, FDA posted two drug-related Warning Letters. One was issued to a drug packager and listed two cleaning validation issues. The other was issued to a manufacturing firm that received a 25-page...
View ArticleFDA Addresses Cell and Gene Therapy Manufacturing Challenges
At the ISPE Biopharmaceutical Manufacturing conference held virtually in early June, CBER Division of Manufacturing and Product Quality Facilities Reviewer and Investigator Ekaterina Allen reviewed...
View ArticleFDA Warning Letters Week Of 11/1/2020: Unapproved HTC/P, Hold Times, & FD&C...
FDA posted three drug-related Warning Letters last week. Below are summaries of each. The post FDA Warning Letters Week Of 11/1/2020: Unapproved HTC/P, Hold Times, & FD&C Violations appeared...
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