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# CGMP Violations in Akorn Formulations Review
- URL: https://www.fdaweb.com/cgmp-violations-in-akorn-formulations-review/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158386

An FDA review of records submitted by Akorn Formulations India Private Limited, a manufacturer of over-the-counter drugs in Hyderabad, Telangana, India, in response to an agency request, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. A 12/17/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akron-formulations-india-private-limited-693938-12172024?ref=fdaweb.com) says the specific violations were:

- failure 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; and
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter notes that on 10/15/24 Akorn recalled its OneLAX docusate sodium liquid stool softener laxative due to CGMP violations. It recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Akorn’s products were placed on an 11/26/2024 Import Alert. The company was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.