GMP Consulting Success Stories — Real Results

A mid-size dietary supplement manufacturer was facing its first FDA inspection with no formal GMP documentation or quality system in place. The company had been operating for three years with informal processes, handwritten batch notes, and no structured training program. With the FDA inspection notice received, they had a narrow window to build a compliant quality management system from the ground up under 21 CFR Part 111 requirements.

• Complete 21 CFR 111 gap analysis identifying 47 non-conformances
• Built full documentation system: 45 SOPs, batch production records, and training matrices
• Developed and delivered comprehensive employee training program across all shifts
• Conducted 2 mock FDA inspections to pressure-test readiness before the real audit

An OTC drug manufacturer received an FDA Form 483 with 8 observations following a routine inspection. The citations covered critical deficiencies in batch record integrity, cleaning validation gaps across three production lines, and an inadequate change control system. The company faced escalation to a Warning Letter if corrective actions were not demonstrated quickly and effectively. With manufacturing operations at stake and a follow-up inspection expected within months, the clock was ticking.

• Implemented robust CAPA system with root cause analysis for each of the 8 observations
• Redesigned batch production records with built-in verification steps and review signatures
• Developed cleaning validation protocols for all production equipment and wrote change control SOPs
• Retrained all production and quality personnel; coordinated facility upgrades for compliance

An established cosmetics brand with over a decade in the market had no prior GMP system and needed to comply with the new Modernization of Cosmetics Regulation Act (MoCRA) before enforcement deadlines. The company manufactured 200+ SKUs across skincare and color cosmetics, had no adverse event reporting procedures, and had never undergone an ISO certification process. Their labeling also required updates to meet new FDA requirements, and their facility had never been registered with the FDA.

• Full ISO 22716 implementation covering production, quality control, storage, and distribution
• Completed FDA facility registration and product listing for all 200+ SKUs
• Built adverse event reporting system and serious adverse event (SAE) escalation procedures
• Conducted comprehensive label review across entire product catalog to meet MoCRA standards