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# API Deviations at Aspen Biopharma Labs
- URL: https://www.fdaweb.com/api-deviations-at-aspen-biopharma-labs/
- Published: 2025-03-25T12:00:00.000Z
- Updated: 2026-09-14T14:56:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158882

A 9/16-9/21/2024 FDA inspection at the Aspen Biopharma Labs Private Limited drug manufacturing facility in Hyderabad, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 3/5 Warning Letter says the specific deviations were:

- failure to design and construct buildings and facilities used in the manufacturing of API in a manner to minimize potential contamination and facilitate appropriate cleaning, maintenance, and operations;
- failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting the predetermined quality attributes, and failure to adequately validate written procedures for the cleaning and maintenance of equipment;
- failure to have originals or copies of records readily available and promptly retrievable during the retention period; and
- failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

The letter notes that following a teleconference with FDA, Aspen agreed to a nationwide recall of all products distributed in the U.S.

FDA acknowledges the firm deregistered its facility on 1/6, but says it is unclear whether it intends to cease production of drugs for the U.S. market and asks for clarification. The agency recommends that Aspen engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. FDA placed the firm’s drugs on a 1/15 Import Alert.

Aspen 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.