FDA Issues Warning Letter to Aspen Biopharma’s API Facility in Hyderabad

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs Private Limited, citing serious cGMP violations at its API manufacturing facility in Sangareddy, Hyderabad. The site (FEI 3012796281) was audited in September 2024 by FDA investigaotrs Khalid M. Khan and Pushpa S. Jayasekara. Key cGMP deviations observed include:

• Facility Design Issues raising contamination risks between high-potency toxic components and non-toxic drug substances
• Process Validation Deficiencies: Failure to validate commercial batch sizes of API intermediates
• Cleaning Validation Failures: Absence of documented cleaning validation program, residues in “cleaned” equipment.
• Data Integrity Issues, backdated QC lab records
• Stability Testing Deficiencies: Inadequate stability data to justify retest periods and expiry dates.

Facility Design:

Multiple facility design issues were observed with no proper separation for high pharmacological activity or toxic materials. Manufacturing areas being exposed to the outdoor environment and the facility was in a state of disrepair. This creates risk of cross contamination of non toxic drug substances from highly toxic components as well as contamination of drug substances from open environment.

Failure to Validate Manufacturing process

Aspen failed to validate commercial lot sizes of API intermediates instead relying on studies conducted on development lot sizes and with different equipment. FDA did not accept Aspens argument that it found no significant variation between commercial lots and developmental lots. FDA contended that process performance qualification (PPQ) studies incorporating the use of appropriately qualified equipment and validated test methods are necessary prior to commercial distribution

Cleaning Validation Concerns:

Aspen did not perform cleaning validation studies despite an internal deviation report which identified the need to implement a cleaning validation. Moreover FDA auditors also observed a manufacturing equipment labelled “Clean” that contained liquid with an unidentified floating residue on product-contact surfaces

Data Integrity  / Document control issues:

The quality system did not ensure the accuracy and integrity of data and failed to ensure adequate document control over paper and electronic records. Aspen even provided a written statement on letterhead admitting to backdating a QC lab document and lack of appropriate original data to support some shipments to US.

Stability Testing Deficiencies

There was no documented stability program to determine appropriate storage conditions, retest periods, or expiry dates for APIs.  There was no adequate data to support the retest date for drugs shipped to US

FDA recommended Aspen to recall all the drugs distributed in US and also placed drugs from the Firm on an Import alert (66-40). Aspen initiated recall of all the products distributed in US. Aspen also deregistered the facility with USFDA.

FDA Warning Letter – Aspen Biopharma (March 2025)