COMPANY FAILED TO CONDUCT QUALITY AUDITS, WARNING LETTER SAYS
The FDA has warned Applied Water Engineering for manufacturing its dialysis devices without conducting quality audits or performing necessary complaint response procedures. One of the firm's devices also lacked premarket approval, the agency said.
During inspections July 11-14, 2006, several current good manufacturing practice violations were also discovered that made the firm's PA2000 and SPD reverse osmosis water purification systems as well as its Bicarb Mixers adulterated, according to the Dec. 27 warning letter. The letter was posted to the FDA website Jan. 23.
The FDA said the company failed to maintain:
Procedures to identify, document and validate design changes;
Procedures to implement corrective and preventive actions;
Customer service call documents;
Process control procedures;
Finished device acceptance procedures;
Personnel training documents;
Device history records; and
Management review procedures.
The warning letter can be seen at www.fda.gov/foi/warning_letters/g6199d.pdf (http://www.fda.gov/foi/warning_letters/g6199d.pdf).