USFDA completes inspection at FDC’s sterile ophthalmic manufacturing facility

21 Aug 2018 Evaluate

US Food and Drug Administration (USFDA) has completed inspection of FDC’s sterile ophthalmic manufacturing facility located at MIDC Industrial Area at Aurangabad in the state of Maharashtra.

The inspection was carried out in relation to the Ophthalmics products being exported to USA market. The USFDA has made 8 observations for the facility. However, the company continues to export its Ophthalmics products to USA market.

FDC is engaged in manufacture of specialized formulations, and oral rehydration salts (ORS).

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