FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to India-based Aspen Biopharma Labs (Aspen) in March 2025 following its inspection of the company’s facility in Malakpet Village, Rangareddy, in Hyderabad, India. The inspection took place Sept. 16–21, 2024. According to the warning letter, FDA inspectors found significant deviations from current good manufacturing practice (CGMP) in the production of APIs (1).

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B),” FDA stated in its March 5, 2025 letter (1).

Deviations found during the inspection include, but are not limited to:

• a failure in the design and construction of the buildings and facilities used to manufacture the API in a way that minimizes potential contamination and facilitates appropriate cleaning, maintenance, and operations

• failure to demonstrate that the company’s manufacturing process can manufacture an API in a reproducible manner while meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintaining equipment
• failure to provide records, either originals or copies, that are readily available and promptly retrievable during the retention period
• failure to design a documented, ongoing stability testing program that monitors the stability characteristics of API and to use the results for confirming appropriate storage conditions as well as for retest or expiry dates (1).

FDA’s warning to Aspen is the latest in a series of warning letters the agency has issued this year to India-based API manufacturers. In February 2025, the agency separately issued warning letters to Jagsonpal Pharmaceuticals (Jagsonpal) and Tyche Industries (Tyche) regarding deviations from CGMP for APIs (2,3).

In the warning letter to Jagsonpal, FDA based its observations on an inspection conducted on March 20, March 27, and April 3, 2024 at the company’s facility in Bhiwadi Dist., Alwar, in Rajasthan, India. During its inspection, the agency observed a failure of the company’s quality unit to exercise its responsibility to ensure compliance with CGMP in the manufacture of the API produced at the company’s contract facility. In addition, the inspector was denied entry by persons present at the site upon arrival on March 15, 2024, only to be granted entry on March 20, 2024; however, during inspection, access to requested documents was limited. Finally, a (b)(4) drug was manufactured at an unregistered facility and was not listed by the company as required under Code of Federal Regulations (CFR)Title 21, Part 207.41(a) (4), which caused the (b)(4) drug to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

“[F]ailure to provide current listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p),” FDA stated in the letter (2).

Meanwhile, the warning letter to Tyche was based on an inspection conducted at this company’s Sarpavaram, Kakinada, India, manufacturing plant on Aug. 12–16, 2024. In this letter, the FDA inspector observed several deviations, including but not limited to:

• a failure to record all quality-related activities at the time these are performed
• failure to clean equipment and utensils to prevent contamination or carry-over of any material that can alter the quality of the APIs produced beyond the official or other established specifications
• failure to test the identity of each batch of incoming production material (3).

References

1. FDA. Warning Letter: Aspen Biopharma Labs Private Limited. fda.gov, March 5, 2025 (accessed March 27, 2025).
2. FDA. Warning Letter: Jagsonpal Pharmaceuticals Limited. fda.gov, Feb. 5, 2025.
3. FDA. Warning Letter: Tyche Industries Ltd. fda.gov, Feb. 6, 2025.
4. CFR Title 21, 207.41(a) (Government Printing Office, Washington, DC), https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207/subpart-D/section-207.41.