Aurobindo Pharma Gets 11 Observations From U.S. FDA For Its Telangana Plant
The U.S. Food and Drug Administration has issued a form 483 with 11 observations to Aurobindo Pharma Ltd.’s Unit 16 in Telangana, which makes sterile drug products.
The drug regulator had inspected the unit between Feb. 22 and March 1. The unit had received a form 483 containing three observations in May last year.
The observations pertain to procedural lapses and not providing adequate training to employees, among others.
Form 483 Observations
- The responsibilities and procedures applicable to the quality control unit aren’t fully followed.
- Control procedures aren’t established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- There is a failure to thoroughly review any unexplained discrepancy whether the batch has been already distributed.
- Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
- Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile aren't established and followed.
- Laboratory controls don't include the establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- Appropriate controls aren't exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel.
- Written procedures are lacking which describe in sufficient detail the sampling and testing of components.
- The records for components don't include the identity and quantity of each shipment of each lot, name of the supplier, supplier's lot number and date of receipt.
- The accuracy, sensitivity and specificity of test methods have not been documented.
What Analysts Say
Param Desai, pharma analyst at Elara Capital, told BloombergQuint that the unit isn’t critical to the company’s core operations as of now due to limited pending approvals for this plant. The company hasn’t revealed the revenue contribution from this plant, he said.
Amey Chalke, pharma analyst at HDFC Securities, agreed. He told BloombergQuint that unit 16, which is relatively new, will manufacture injectables and antibiotics. “We believe the current exposure is negligible,” Chalke said. “However, it's likely to be an important unit from the growth perspective."
Shares of the Hyderabad-based pharmaceutical firm remained largely unchanged in early trade today, rising 0.5 percent. The shares have declined over 3 percent in the past six months.