Bioequivalence and Bioavailability Forum • Recalled Paracetamol, a question for CMC gurus

Recalled Paracetamol, a question for CMC gurus [Off Topic]

posted by nobody – 2019-06-28 13:51 (2559 d 19:25 ago) – Posting: # 20365
Views: 12,022

PPS:

The FDA found termites, dead pests, impurities and other serious GMP violations at Bristol-Myers Squibb’s drug facility in Manati, Puerto Rico, during a Jan. 15-Feb. 6 inspection.

The agency investigators discovered that a media fill conducted at the facility resulted in a vial that was murky and contaminated with bacteria. The firm identified the contaminants as mites. As a result, lots of lyophilized drug products were placed on hold.

—
Kindest regards, nobody

Complete thread:

Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-18 17:22 [Off Topic]
- Recalled Paracetamol, a question for CMC gurus Helmut 2019-06-18 18:40
  - Recalled Paracetamol, a question for CMC gurus nobody 2019-06-18 20:44
    - Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 14:56
      - Recalled Paracetamol, a question for CMC gurus Helmut 2019-06-19 15:24
        
        Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 16:03
        
        Recalled Paracetamol, a question for CMC gurus nobody 2019-06-19 16:04
        
        Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 16:31
        
        Recalled Paracetamol, a question for CMC gurus nobody 2019-06-19 16:41
        
        Recalled Paracetamol, a question for CMC gurus Helmut 2019-06-19 16:48
        
        Recalled Paracetamol, a question for CMC gurus ElMaestro 2019-06-19 17:10
        
        Recalled Paracetamol, a question for CMC gurus nobody 2019-06-19 17:40
        
        Recalled Paracetamol, a question for CMC gurusnobody 2019-06-28 11:51
        
        Recalled Paracetamol, a question for CMC gurus jag009 2019-07-01 02:41