FDA 483 - ABS Corporation - August 11, 2023

An FDA inspection of ABS Corporation, a contract manufacturer located at 7031 N 16th St, Omaha, NE, was conducted from August 8-11, 2023. The inspection, led by Investigator Torrey M Ward, identified four repeat observations regarding the firm's quality system and manufacturing controls.

Observation 1 noted that written records are not always made for investigations into unexplained discrepancies and out-of-specification (OOS) results. Specific examples included an inconclusive OOS investigation for yeast in Pyrantel Pamoate finished product (manufactured 1/25/2023) that was released for distribution without a manufacturing investigation. Additionally, for Canine Aspirin Tablets (lot (b)(4), manufactured 1/27/2021), an OOS for Salicylic Acid led to a specification change without written justification or root cause investigation. Furthermore, on 3/24/2023, QC Room Clean Verification was not obtained before production of CL Solutions Regency 20X Teat Dip, and no Non-Conformance Report was opened.

Observation 2 stated that the firm failed to establish adequate written procedures for production and process controls to assure drug product identity, strength, purity, and quality. The firm could not provide documentation for production and cleaning process validation. Examples included the lack of a process validation protocol for Canine Aspirin Tablets, inadequate equipment qualification records for a (b