Today, we are releasing our Annual Report that highlights the most frequently cited FDA Inspection […]
As per the Federal Code of Regulations, 21 CFR 211.180(e), product reviews are to be […]
Welcome 2022! As we say goodbye to the old year, let us take a few […]
According to the Code of Federal Regulations (21 CFR 211.150 Distribution procedures), each manufacturer must […]
According to the Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action), each […]
On November 15, 2021 GMP Trends® posted Issue #1076 featuring observations pertaining to data integrity […]
A company recently received the following observation: …..Written MDR procedures have not been developed, maintained […]
According to the Code of Federal Regulations 21 CFR 820.90(b)(2): Each manufacturer shall establish and […]
Raw material testing is essential to ensure the identity, strength, quality, and purity of the […]
In response to the COVID-19 public health emergency, the FDA is limiting unnecessary contact by […]