# FDA 483 - Sun Pharmaceutical Industries Ltd. - June 11, 2019

Source: https://www.keypedia.com/records/483/sun-pharmaceutical-industries-ltd/46808012-a2fb-45f6-8b29-9e553207cad7

> FDA 483 for Sun Pharmaceutical Industries Ltd. on June 11, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sun Pharmaceutical Industries Ltd.
- Inspection Date: 2019-06-11
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: This FDA Form 483 details observations from an inspection, highlighting deficiencies in manufacturing controls and quality systems.

**Observation 1** notes a failure to follow procedures designed to prevent microbiological contamination of sterile drug products. Specifically, the Aseptic Process Validation Master Plan was not adhered to during a media fill run, resulting in batch contamination. The investigation revealed several "new" operations during this run that were either not recorded in detail or not performed according to written instructions.

**Observation 2** identifies that established laboratory control mechanisms, particularly for environmental monitoring (EM) plate review, are not documented at the time of performance, compromising data assurance. The primary reviewer performed plate analysis almost two hours before the witness review, contrary to SOP QCM-042, which requires simultaneous review.

**Observation 3** indicates inadequate establishment of design plans for design and development activities. For the (b)(4) (Injection, E_J <4> pcg/mL, tbH4> mL & tbH4> mL es L · d <b><4> a M 20 t 9 H - b th d · associate to) product, design activities began in August 2012, but the design plan was only approved in May 2019. Additionally, a device history file demonstrating conformance to an established design plan was absent.

**Observation 4** points out that a process whose results cannot be fully verified by subsequent inspection

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## Related Officers

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Company: https://www.keypedia.com/companies/sun-pharmaceutical-industries-ltd/0ee9565e-1ff7-4ffa-b6ad-c38bccdc32e6

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7