The QMN Weekly Bulletin

India’s Strides Gets 483 for Quality Problems

June 16, 2017

Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets.

An investigation from May 22 to 26 revealed at least 10 complaints that the company’s capsules were lumping, melting or otherwise sticking together in the bottle.

Although the company investigated the manufacturing process, it failed to find the root cause to take the appropriate corrective actions, and it remained unclear if the quality measures taken were representative of the entire batch, according to the Form 483.

The inspectors also found the company’s sampling plans were not scientifically based, the manufacturing batch record directions were inadequate, and procedures and process controls for quality were not written down.

Order your copy of GMP Inspection Preparation Checklist and know the kinds of questions regulatory investigators ask and the opportunity to practice answering them. The checklist is designed for internal audits — to prepare staff to answer investigator questions — and to spot and correct mistakes before the investigators ever arrive.

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