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# CGMP Violations at Wong Lap Kwong
- URL: https://www.fdaweb.com/cgmp-violations-at-wong-lap-kwong/
- Published: 2018-01-23T12:00:00.000Z
- Updated: 2026-09-14T23:16:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140568

A 9/18-9/22/17 FDA inspection at Wong Lap Kwong Medicine Company, Kowloon, Hong Kong, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/11 [Warning Letter](http://nicksbistromarietta.com/nicks-bistro-menu/?ref=fdaweb.com) says the specific violations were: 

- failing to establish adequate written responsibilities and procedures applicable for the quality control unit and to follow such written procedures;
- failing to ensure the identity of components, including active ingredients and excipients from various suppliers;
- · failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and the firm’s quality control unit did not review and approve the procedures, including any changes; and
- failing to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of and to maintain written records of calibration checks and inspections of equipment used in the manufacture, processing, packing, and holding of a drug product.

The agency recommends the company engage a qualified consultant to assist it in meeting CGMP requirements. “The consultant should comprehensively assess manufacturing operations to ensure that all systems and processes, and ultimately the products you manufacture, conform to FDA requirements,” the letter says.

FDA also found some of the company’s labeled inactive ingredients are not in the agency’s inactive ingredient database for approved drug products, and says it is not aware of the ingredients being used as inactive ingredients in any OTC drug product. “We remind you that it is your responsibility to ensure that your product contains only suitable inactive ingredients that are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity,” the letter says.

The letter says the company’s response to the inspection observations was inadequate because it did not adequately address the violations observed, and lacked detail and evidence to support its commitments. The firm was placed on an import alert 1/18\. Wong Lap Kwong was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.