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 repackager for cleaning validation issues. Interestingly, cleaning validation (or lack thereof) was a focus of one of the previous week’s Warning Letters.
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 for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.
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 latter dealt with adulterated cord blood product.
This week, FDA posted one warning letter to an OTC pharmaceutical firm, but none to device, pharmacy, or outsourcing firms. CBER issued one untitled letter to a firm that markets cellular products from the umbilical cord or amniotic membranes.
FDA Warning Letters Week of 07/26/20: Unapproved HCT/P & OCT Products, Repeat Deficiencies, & Testing into Compliance
This week the FDA posted two warning letters to firms that sold cord blood products without having an active IND or approved BLA. There were also two warning letters posted to the manufacturers of OTC drug products.
FDA Warning Letters Week of 07/19/20: Data Integrity, Unapproved New Devices, & Repeated Failures at Multiple Sites
This week, FDA posted two warning letters to drug manufacturers and one to a device manufacturer. The warning letter to Stason Pharmaceuticals (Irvine, CA) includes the most granular list of requested data integrity remediation activities that I’ve seen FDA provide, to date.
This week FDA posted two warning letters to device manufacturers and two to drug manufacturers. One of the drug manufacturers produces homeopathic drugs, which continues FDA’s focus on this area of the industry.
This week FDA posted one warning letter to a drug firm and two to compounding pharmacies. One compounding pharmacy received a warning letter from an inspection ending in 2018, and we include the 10-observation form 483.
A slow week, two warning letters to compounding pharmacies along with an untitled letter. No device or pharma warning letters posted.