FDA 483 - Emcure Pharmaceuticals Limited - February 04, 2015

**FDA 483 Summary for Emcure Pharmaceuticals Limited**

**Company Name:** Emcure Pharmaceuticals Limited **Inspection Dates:** January 27, 2015 - February 4, 2015 **Location:** Hinjwadi, Pune, India **Type of Establishment Inspected:** Sterile Injectable and Solid Oral Dosage Drugs

**Main Violations/Issues:** 1. **Incomplete Laboratory Records:** The inspection revealed that laboratory records did not include complete data from all necessary tests to ensure compliance with established specifications. Specifically, environmental monitoring data was found unreliable as microbiologists failed to collect required samples but documented them as collected with zero CFU results.

2. **Environmental Monitoring Concerns:** Since May 2013, there were no action limit findings during environmental monitoring, raising concerns about the reliability of the data. Video evidence confirmed that samples were not collected as claimed in records.

3. **Personnel Monitoring Errors:** Personnel monitoring logs and microbiology incubator inspections showed discrepancies, including missing plates and incorrect recording of results.

4. **Procedural Lapses in Sterility Assurance:** Procedures to prevent microbiological contamination were not adequately established or followed. Instances included improper handling of equipment and materials, such as placing a cup on the floor and using it in sterile areas without proper procedures.

**Regulatory Framework:** The observations fall under the FDA's regulatory oversight for ensuring compliance with good manufacturing practices (GMP) to maintain drug product quality and safety.

**Required Actions:** Emcure Pharmaceuticals must address these observations by implementing corrective actions to ensure complete and accurate laboratory records, reliable environmental monitoring, adherence to personnel monitoring protocols, and strict compliance with procedures to prevent contamination. The company is encouraged to discuss objections or corrective actions with FDA representatives and submit detailed plans for rectification.