3. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
From February 16 to March 20, 2018, you tested [redacted] batches of [redacted] API for [redacted]. All results were reported as passing. However, during the FDA inspection on March 28, 2018, we requested retesting the same batches under our observation. All retest results were OOS.But the visual testing - that was probably performed to SOP.
A batch of [redacted] finished product, initially tested on May 25, 2017, was also retested on March 28, 2018, and found to be OOS...
...In a Field Alert Report (FAR) of July 20, 2018, regarding OOS [redacted] results, you indicated that “analysts performing the [redacted] test did not perform the analysis in accordance with procedures and did not record the data accurately in the past.” Also, “there may be instances where testing results for the Karl Fisher test, gas chromatography, infrared spectroscopy and ultraviolet spectroscopy were not recorded accurately.”