FDA WARNING_LETTER - Angiplast Private Limited - January 30, 2020

On May 14, 2020, the FDA issued a Warning Letter to a firm in Ahmedbad, India, following an inspection from January 27-30, 2020. The inspection revealed that the firm's urinary drainage bags, classified as medical devices, were adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain procedures for acceptance of incoming product (21 CFR 820.80(b))**: Five of nine PVC inlet tube lots for urinary drain bags did not meet specified length or weight criteria but were accepted and used in finished devices. The firm's response, which involved increasing tolerance and not addressing nonconforming product identification or past records, was deemed inadequate. 2. **Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a))**: * The CAPA procedure did not define how statistical methodology would be employed, and no statistical analysis was performed. The firm's revised procedure was unclear on implementation and rationale for sampling frequency. * CAPA 02/2017-18 was closed without verification of effectiveness. The revised procedure did not ensure