FDA finds major manufacturing issues at key Aurobindo facility

Indian pharmaceutical firm Aurobindo has been rocked by an USFDA review which identified nine major issues with its Unit 4 facility in Hyderabad, India, which focuses on the manufacture of generic sterile injectables, ophthalmics and low volume parenterals.

The observations were made during the US regulator’s inspection of the premises between 12 and 20 February, 2018, and focus primarily on the low standards of equipment maintenance and quality control, as well as instances of infestation and lack of adequate employee training.

The news is particularly damaging for Aurobindo as the site in question is responsible for contributing 15% of the company’s total US sales, with several of its pending approvals related to products manufactured at the facility.

The full list of observations is as follows:

1. Deficient system of maintaining equipment
2. Equipment and utensils not cleaned, maintained and sanitised
3. Equipment used not of appropriate design
4. Building not free of infestation
5. Procedures for cleaning and maintenance equipment are deficient
6. Employees lack training
7. Quality control criteria fail to include appropriate levels of acceptance or rejection
8. Laboratory control mechanism are not followed and documented at time of performance
9. Appropriate controls over computers not maintained

Aurobindo is now expected to respond to the observations within 15 days and propose an action plan to correct the noted issues. In the event that they cannot be resolved satisfactorily, the FDA will issue the plant with a warning letter, impacting future approvals of drug’s manufactured at the site