“You have to learn the rules of the game. And then you have to play better than anyone else.” - Einstein
Pharmaceuticals • Bio-Tech • Medical Devices • Cosmetics
Turn FDA Compliance into a Competitive Advantage
Where competition is fierce and stakes are high, IQA offers a strategic advantage in building quality into FDA-regulated products. Our approach combines technical expertise with practices that enable resourcefulness and agility so your team can bring quality products to market faster and within budget. With the highest level of integrity, IQA is committed to minimizing risk and maximizing value for its clients.
92% of all FDA actions are avoidable
Keeping apprised of trends, regulations, and new technologies ensures compliance with Good Manufacturing Standards (cGMP) and keeps you in good standing with the FDA.
The FDA increased issuance of warning letters by 53% from 2017 to 2018.
The FDA has a particular focus on homeopathic drug manufacturers and manufacturers of human cell and tissue products, with three and four warning letters, respectively, in 2018.
483’s issued in 2017 and 2018 focused primarily on:
Lack of validation; Data integrity; Procedures not written, or not fully followed; Poor investigations of discrepancies or failures (OOS/CAPA); Absence of written procedures.
As one former VP of Manufacturing of a Global Biopharma company put it: “One moderately bad 483 possibly costs us - all in - about $250,000…”
- Ongoing and increased attention in process validation.
- Increasing enforcement actions for stem cell product manufacturers, as well as manufacturers of human tissues and cellular products.