WL Apollo Health And Beauty Care, Inc. MARCS-CMS 593033 — DECEMBER 23, 2019
1. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
Your firm contract manufactures over-the-counter (OTC) drug products, some of which are labeled to be used for children. During a review of an out-of-specification (OOS) investigation for (b)(4) content in your bulk (b)(4) lot (b)(4), our investigator identified multiple discrepancies between the human machine interface (HMI) data, and the entries made by operators into batch records. For example, the operator recorded (b)(4) the batch during Step (b)(4) for (b)(4) at (b)(4). However, HMI data indicated that (b)(4) were not operational at that time.
