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# CGMP Violations in Apollo Health Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-apollo-health-inspection/
- Published: 2020-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:57:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145773

An 8/12-8/16/19 FDA inspection at Apollo Health and Beauty Care, North York, Ontario, Canada, a contract manufacturer of over-the-counter drug products, including some labeled for use by children, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 12/23/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apollo-health-and-beauty-care-inc-593033-12232019?ref=fdaweb.com) says specific violations were: 

- failing 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 manufacturing, processing, packing, and holding of a drug product;
- failing to establish adequate written procedures for production and process control designed to assure those drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed.

Two of the inspection observations were repeated from a 12/2016 FDA inspection. The agency said that based on the nature of the violations it strongly recommended that the company engage a qualified consultant to assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market. It also recommended that the consultant perform a comprehensive audit of the firm’s entire operations for CGMP compliance and that the consultant evaluate the completion and efficacy of the firm’s corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

Apollo was placed on an import alert on 12/16/19\. It was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.