Types of FDA Officers who conduct inspections: FDA Investigators who perform site inspections in the US, are often employees from local district’s FDA field office. Occasionally, personnel from the center or field offices of other districts may join inspections for training or resource purposes. FDA inspectors may have a wide range of backgrounds. The inspection team may…

The Chicken and the Horse Once upon a time, a baby chicken named Sammy lived in a small field owned by farmer Joe. Sammy was a very happy chicken. He always maintained a positive outlook on life and brushed off all negativity around him. Now Sammy became friends with a…

The lockdown is easing, and we’re in a yellow zone. Pretty soon, we’ll be green. The world is waking up from this surreal experience. I was looking forward to a beautiful, lazy, soft open after this social slumber, but it wasn’t so. In the past 12 days, the resentment towards social-distancing has morphed into a collective outrage towards social injustice. And rightly so. The mask that helped us from breathing in the virus has suddenly become a symbol of widespread protests representing the quote, “I can’t breath,” painfully spoken by an African American male while a white policeman was pressing his knee on the victim’s neck.

The culture of quality and compliance has lately become a buzz phrase among my Pharma colleagues. People often list the root causes, as lack of accountability, incompetent or corrupt leadership, an absence of consequences, and deeply ingrained cultural norms and expectations. People can skirt the law with impunity and get…

April 26, 2019 OVERVIEW When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. …

Five plus One!! Hmmmmm The Dirty (half) dozen. Only because of that extra cowbird egg. But what can I do? 😊😊😊

The Love Birds!! Dad Finch Feeds Mommy Finch! So cute!!! Beyond printed words. Watch the video!

Sitting Pretty! So the lady Finch is finally settling down. I see her fly off occasionally to feed at the bird seeds I spread on my patio. Other than that she’s just doing her job!!

Four eggs plus one from a cowbird! Not fair!