Case Study 1 OTC Cosmetic Manufacturer Remediation and Quality Systems Restoration
Issue: A medium-sized manufacturer of OTC cosmetics (OTC sunscreens, dandruff shampoos and salicylates) received a 15 point warning letter from the FDA. They were required to remediate and upgrade the existing quality system.
Solution: The IQA team completed a process flow map, prepared a gap analysis and analyzed existing products, systems and procedures. We created a risk matrix to assess safety, efficacy, regulatory and compliance risks as well as cGMP compliant procedures and documentation. We then implemented validation strategies, produced cleaning, and microbial reduction programs for equipment and processes, and filed establishment registrations and FDA required documentation.
The company was able to produce and ship the product within 8 months in a compliant manner
Scrap and waste was reduced by 45% over a 6 month time period
The company retained business stature and production ramp-up to 36% over previous levels.
The FDA returned within 18 months with 0 483 observations