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# CGMP Issues in Enprani Inspection
- URL: https://www.fdaweb.com/cgmp-issues-in-enprani-inspection/
- Published: 2019-09-10T12:00:00.000Z
- Updated: 2026-09-15T01:48:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144960

A 3/11-3/15 FDA inspection at Enprani Co., Seoul, South Korea, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. An 8/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/enprani-co-ltd-580548-08152019?ref=fdaweb.com) says specific violations were: 

- failing 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;
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products;
- failing to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and

· failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel initiate changes in master production and control records.

The letter says the firm’s quality control system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured. It tells the company to provide **(1)** a comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States, with a detailed description of the scope and root cases of data integrity lapses; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and **(3)** a management strategy for the firm including details of a global corrective and preventive action plan.

Based on the nature of the identified violations, FDA strongly recommends that Enprani retain a qualified consultant to assist it in meeting CGMP requirements. The agency also recommends that the consultant perform a comprehensive audit of the company’s entire operation for CGMP compliance and that the consultant evaluate the completion and efficacy of corrective and preventive actions before Enprani pursues resolution of its compliance status with FDA.

The letter also raises labeling issues and says the company has not fulfilled its registration and listing requirements under the Federal Food, Drug, and Cosmetic Act. The company was placed on import alert 7/15.

Enprani was told to respond with a list of specific steps it has taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.