US Specialty Formulations LLC – FDA 483, Jul 23, 2019

The FDA Form 483 details multiple significant violations observed during an inspection. The facility lacks written procedures for production and process controls to ensure drug product identity, strength, quality, and purity. Specifically, compounding and filling processes for drug products like Betamethasone, Medroxy, and Monsels Paste are not validated.

Stability testing results are not used to determine expiration dates. For example, Multivitamin lot 01RH0413A was relabeled with a new expiration date after being expired for five months, and other products like Ethanol, Monsels Paste, Pyridoxine, and Methylcobalamin have expiration dates exceeding available stability data.

Drug product release testing is deficient; Sarapin finished lot 01RM1502A was released without quantifying the active pharmaceutical ingredient. Furthermore, drug products failing specifications, such as Strong Iodine Solution lot 01RJ1522A and B-Complex w/ Chromic Chloride lot 01RJ1534A, were released.

The firm's Out-of-Specification (OOS) retesting procedures are not followed, as seen with Betamethasone lot 01RK1517A. Test methods for finished product tests, including B-Complex - Chromic Chloride, Betamethasone, Medroxyprogesterone, and Methylcobalamin potency, are not validated.

There are no written procedures for reprocessing batches, and Betamethasone lot 01RK1