Summary of FDA inspection of Hetero Labs Unit-X

General Information:

  • Facility: Hetero Labs Limited, Unit-IX, located in Narasapuram Village, Andhra Pradesh, India.
  • Inspection Dates: 09/19-26/2025.
  • Type of Establishment: API (Active Pharmaceutical Ingredient) Manufacturer.
Key Observations: 1. Unregistered Testing Laboratory:
  • The facility used an unregistered testing laboratory for API testing, which was not referenced in their Drug Master Files (DMFs). This laboratory was located away from the main facility.
  • Finished API samples with matching batch numbers and dates were discovered, indicating collaboration with the unregistered lab.
  • The firm did not have a quality agreement established with this unregistered testing facility conducting analysis on products manufactured by your firm.
  • Multiple examples of API intermediate samples were found at the unregistered testing laboratory.
  • Numerous uncontrolled notebook pages containing analytical test results for APIs and API intermediates manufactured at this facility were found in the unregistered laboratory.

2. Undocumented Offsite API Warehouse:

  • Finished APIs and intermediates intended for the US market were released to an offsite, undocumented warehouse without proper documentation.
  • The warehouse lacked procedures and records for receiving, inspection, storage condition monitoring, investigations of excursions, and segregation of materials.

3. Inaccurate Batch Production Records:

  • Raw materials and quantities documented in batch production records did not align with actual API yields.
  • Batch production records did not fully document the total output, and there were discrepancies in the quantities of drums used and stored.

4. Inadequate Document Control:

  • The Quality Unit failed to ensure adequate oversight and control of GMP documents
  • A "Training Agreement" with the unregistered testing laboratory contained inconsistencies, such as the signatory not being employed at the time of signing.
  • GMP documents were found destroyed in a scrap bag in the Quality Control laboratory, violating data integrity principles.

5. Failure to Reconcile Identification Labels:

  • The firm failed to reconcile the quantities of identification labels issued, used, and returned
  • Drums labelled with the same batch number were found in the undisclosed warehouse, in addition to the number of drums documented as used to produce the batch number.

6. Failure to Document and Investigate Out-of-Specification (OOS) Results:

  • The firm failed to document and investigate Out of Specification (OOS) results for the firm's list of OOS for API and intermediates
  • Only passing results were documented for products and lots that were known to have analytical data, and lots with only passing results were noted.
  • These lots have all been released and distributed for further manufacturing of products intended for the US market.

Conclusion: The inspection uncovered several critical deficiencies in Hetero Labs Limited, Unit-IX's quality control processes, documentation practices, and oversight of testing and storage facilities. These issues raise concerns about the reliability and integrity of their API manufacturing processes and the safety of products meant for the US market.

There are a total of 6 observations, and some of them could have the potential to result in a Warning Letter if not addressed to the satisfaction of the USFDA. We reviewed the number of DMFs filed by Hetero and attempted to correlate it with other publicly available data. The following DMFs could be affected by this FDA inspection, as they may have been manufactured at Unit-IX. However, this is only an educated guess. 




Location: Mumbai, Maharashtra, India

Comments

Post a Comment

Popular posts from this blog

Gland Pharma is expected to secure 180-day exclusivity for Angiotensin II Acetate.

Image
This week, Gland Pharma received approval from the US FDA for the Angiotensin II Acetate Injection 2.5 mg/mL. Gland Pharma's Angiotensin II Acetate Injection is a generic version of La Jolla Pharma's Giapreza. Giapreza's sales are approximately $58 million in the U.S. market for the twelve months ending March 2025. Angiotensin II (ATII) is a naturally occurring peptide hormone that produces endocrine, autocrine, paracrine, and intracrine hormonal effects. It is a potent direct vasoconstrictor that narrows both arteries and veins, subsequently raising blood pressure. Its half-life in circulation is approximately 30 seconds; however, in tissue, it may extend to 15-30 minutes. ATII increases the secretion of ADH and ACTH and may enhance sympathetic effects through direct actions on postganglionic sympathetic fibres. Additionally, it acts on the adrenal cortex, prompting the release of aldosterone. Several patents are listed in OB by La Jolla Pharma’s Giapreza product.  Product...
Read more

Medical Reimbursement System in the US, J-Code, and the Potential Impact on 505(b)(2) Applications with Recent Changes

US Medical Reimbursment System The medical reimbursement system in the United States is very complex. I am not aware of any such system existing at the national level in India, so I cannot draw any parallels. In India, health insurance is primarily for hospitalisations, and, based on my information (which is mainly based on my health insurance), other reimbursements are generally not covered. However, I could be wrong. In the United States, there is HCPCS. Healthcare Common Procedure Coding System (HCPCS).  HCPCS is a standardised coding system used mainly for billing and processing health insurance claims, especially for Medicare and Medicaid.  The Centers for Medicare & Medicaid Services (CMS) maintains it. HCPCS is divided into two levels: Level I, which uses Current Procedural Terminology (CPT) codes, and Level II, which provides codes for products, supplies, and services not included in CPT.  You will notice that in the United States, almost everything is covered...
Read more