United States Food and Drug Administration (USFDA) has conducted an unannounced inspection of Rubicon Research’s manufacturing facility located at Plot No. A-17, Special Economic Zone, Phase- II, Industrial Area, Pithampur, District Dhar, Madhya Pradesh from June 29, 2026 to July 03, 2026.
This was the first USFDA inspection of this facility since its acquisition by the company last year. In the 12 months since the acquisition, it completed the integration of the facility, implemented its quality management systems and completed regulatory filings that initiated the inspection requirement. Upon conclusion of the inspection, a Form 483 containing 2 observations was issued to the company. The observations are procedural in nature and do not relate to data integrity.
Rubicon Research is a pharmaceutical formulations company, driven by innovation through focused research and development, with an increasing portfolio of speciality products and drug-device combination products targeting regulated markets and in particular the United States.
| Company Name | CMP |
|---|---|
| Wework India Mgmnt. | 738.30 |
| Rubicon Research | 1302.75 |
| Aegis Vopak Terminal | 258.35 |
| Mallcom (India) | 1029.05 |
| Inducto Steel | 64.56 |
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