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mercredi 28 octobre 2020
WL KVK-Tech, Inc. - OCTOBER 08, 2020
2. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced. (21 CFR 211.188)
During packaging of one lot of hydroxyzine HCl tablets, USP 50 mg, our investigator observed that the air pressure gauge reading was outside the acceptable range for your capper, although a conforming value was recorded in the batch record. In addition, our investigator observed readings on other gauges that were lower than your validated parameters.
Our investigator also noted that in the batch record for promethazine HCl tablets, USP 25 mg, your employees failed to record actual readings for the air pressure for several pieces of packaging equipment, including your slat counter, capper, and (b)(4)...