FDA Warning Letter to JOAMCA Chemical Products (Nov 13, 2001)

A warning letter was sent to JOAMCA Chemical Products on November 13, 2001, citing various violations related to quality control and manufacturing practices. The letter highlighted the firm's failure to validate cleaning procedures for drug-making equipment and maintain records of equipment cleaning. Additionally, JOAMCA was cited for lack of written procedures for change control, equipment cleaning and maintenance, and container control. In response to the warning letter, JOAMCA President John Taylor acknowledged the firm's lack of preparedness for the jurisdiction switch from USDA to FDA and committed to compliance with all regulations.

Key Takeaways:

• JOAMCA Chemical Products was cited for failure to establish a quality control unit.
• The firm was found to not validate cleaning procedures for drug-making equipment.
• JOAMCA was also cited for lack of written procedures for change control, equipment cleaning and maintenance, and container control.
• The company was required to correct various violations, including maintaining records of equipment cleaning and records for receipt of labels and/or packaging.
• JOAMCA President John Taylor acknowledged the firm's lack of preparedness for the jurisdiction switch from USDA to FDA.
• The company committed to compliance with all regulations and considered it a learning experience to become a better manufacturer and community neighbor.

Statistics:

• 1 failure to establish a quality control unit
• 2 lack of written procedures for change control, equipment cleaning and maintenance, and container control
• 2 failure to maintain records of equipment cleaning and records for receipt of labels and/or packaging
• 10+ years of manufacturing and distributing cleaning solutions without previous FDA citations
• 20+ years of spotless record before the FDA warning letter

Sources:

• FDA Warning Letter to JOAMCA Chemical Products, dated November 13, 2001.