WARNING LETTER Haw Par Healthcare Limited MARCS-CMS 578581 — AUGUST 19, 2019

CGMP Violations

1.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

You invalidated out-of-specification (OOS) test results for assay for (b)(4), active pharmaceutical ingredient (API) (batches (b)(4) and (b)(4)) without scientific justification. Batch (b)(4) of this API was subsequently used to manufacture multiple batches of your (b)(4) Patch over-the-counter (OTC) drug product. Several batches of OTC drug product made from these OOS API lots also had OOS results for (b)(4) assay. In addition, your API supplier informed you of the potential for (b)(4) to separate and have changes in viscosity. The supplier recommended performing additional processing steps before use in manufacturing...

3.    Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

The computer systems you use to control the operations of your analytical instrumentation do not have audit trail capabilities, including Gas Chromatography (GC) instruments used for drug product stability analyses and Fourier Transform Infrared Spectroscopy (FTIR) and Ultraviolet (UV) spectroscopy instruments used for raw material release testing.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.