A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection.
The quality failures included inadequate process control procedures to ensure conformance to specifications, inadequate testing and validation procedures, inadequate finished device acceptance activities, and failure to document rework and reevaluation activities.
Nonconforming batches with out-of-specification electrolyte concentration were stored without a valid justification. The 483 documents repeat observations for acceptance procedures and testing procedures for the firm’s Diasol liquid acid concentrate.
For example, the inspector found at least five examples of failure to document the final disposition of nonconforming product. The firm had received a July 12, 2017, warning letter from the agency for missing product nonconformity reports and failure to investigate nonconforming products.
Many of the findings were repeat observations, flagging document control procedures, labeling activities, and measuring and test equipment not suitable for the intended purpose.
Read the Diasol East Form 483 here: www.fdanews.com/01-02-19-diasolinc483.pdf.