A Glimpse on recent observations done by USFDA on Indian Pharmaceutical Industries

The USFDA has recently made several observations in Indian pharmaceutical industries. Some of the observations include:-

- *Deficient records-keeping procedures*: Dr. Reddy’s Labs was cited for not maintaining a complete record of all data captured during testing.

- *Lack of employee training*: Dr. Reddy’s was also called out for a lack of employee training, with one employee in the quality unit being overdue on a required training for more than two years.

- *Unsanitary conditions*: Alkem Labs was cited for not maintaining areas of manufacturing, processing and packing in a good state of repair, including no hot water for production workers to wash their hands.

- *Broken equipment*: Alkem was also cited for failing to clean and sanitize equipment and utensils.

- *Poor recordkeeping*: Laurus Synthesis was cited for keeping incomplete records related to batch production and control.

- *Procedural observations*: Torrent Pharmaceuticals received five observations related to procedural issues, including failure to review batch discrepancies and not keeping equipment and tools clean enough.

- *Voluntary Action Indicated (VAI)*: Suven Pharmaceuticals received a VAI tag for its subsidiary’s Hyderabad manufacturing facility, indicating some objectionable conditions or practices but no formal administrative or regulatory actions.

- *Eight observations*: Natco Pharma received eight observations from the USFDA at the end of the inspection at the company's Pharma Division located in Kothur Hyderabad, India.