LSL Industries, Inc. – FDA Warning Letter, Feb 24, 2012

On January 31-February 24, 2012, an FDA inspection of LSL Industries, Inc. in Chicago, IL, revealed that the firm, which manufactures and repacks Class I and Class II sterile disposable devices (e.g., urinary drainage bags, catheterization sets, IV start kits, laceration trays), was not in conformity with Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Failure to maintain process validation (21 CFR 820.75(a)):** The firm did not follow its "Packaging Validation Protocol" (document #01-07), substituting product 1450VA for 1616 without justification. No documentation of rejected seals or defined rejection parameters was provided. Only one of four heat-sealing machines was validated, and no explanation was given for "worst-case" product selections for validation. The firm also failed to qualify sterilization processes for kits containing pre-sterilized single lumen hypodermic needles. 2. **Failure to document changes or process deviations (21 CFR 820.75(c)):** The firm did not re-validate heat-sealing parameters after heating element changes in two of four machines, and no justification was