Akron Formulations India Private Limited

Warning LetterOpen

Mr. RamaRao Kovoor Venkata General Manager – Technical/Quality Operations Akron Formulations India Private Limited 134 - B, IDA - Bolaram Hyderabad 502325 Telangana India Ramarao.k@akronindia.comFEI 3017000602Issued Dec 17, 2024Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017000602.

Violations3

Issue DateDec 17, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Akron Formulations India Private Limited
Location: Mr. RamaRao Kovoor Venkata General Manager – Technical/Quality Operations Akron Formulations India Private Limited 134 - B, IDA - Bolaram Hyderabad 502325 Telangana India Ramarao.k@akronindia.com
FEI Number: 3017000602
Country: India
Issue Date: December 17, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Akron Formulations India Private Limited, a manufacturer of over-the-counter drug products, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its finished pharmaceuticals adulterated. The facility failed to establish an adequate quality control unit with proper authority to approve or reject components, drug products, and materials, and critically, it used active pharmaceutical ingredients from multiple suppliers that were subject to FDA import alerts at the time the products were manufactured and shipped to the United States. These manufacturing and control deficiencies violated Title 21 CFR parts 210 and 211, indicating the company's methods, facilities, and controls did not conform to required standards.

Akron Formulations India Private Limited FDA Warning Letter, December 17, 2024