# FDA 483 - EUGIA Pharma Specialities Limited - March 06, 2018

Source: https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/d9cb86c0-e5ad-44af-927a-41fd164955d9

> FDA 483 for EUGIA Pharma Specialities Limited on March 06, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUGIA Pharma Specialities Limited
- Inspection Date: 2018-03-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: During an FDA inspection, the facility was cited for several violations related to its production and process controls, personnel training, and laboratory control mechanisms.

**Production and Process Controls:** The firm lacks written procedures to ensure drug product identity, strength, quality, and purity. Specifically, the Vial Sealing Machine (PF/VSM-01) has an unsubstantiated operating speed range of REDACTED vials per minute in manufacturing batch records. The worst-case speed of REDACTED vials per minute was never processed during development or validation.

**Personnel Training:** Employees involved in manufacturing, processing, packing, and holding drug products lack adequate training for their assigned functions. The visual inspection qualification procedure (SOP#PPT-07) is insufficient. The training kit for 100% visual inspection of sterile drug products only contains REDACTED glass vial with REDACTED particulate and REDACTED glass vial with a large REDACTED particulate, failing to challenge inspectors with the full range of potential contamination.

**Laboratory Control Mechanisms:** The establishment and changes to laboratory control mechanisms are not drafted by the appropriate organizational unit. The REDACTED Microbial Identification System (QC/VMI-01), installed on 01/10/2011 with REDACTED SW version REDACTED, underwent undocumented software updates from REDACTED to REDACTED, and then from REDACTED to REDACTED on 18/06/20

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## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/eugia-pharma-specialities-limited/c9c73721-7ca2-4457-89c9-f1001123e141

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c