Drug factory · FDA FEI 3008535840
Sintetica Sa
RUE DES ILES, 4, Couvet, Switzerland
No problems found at FDA's last inspection, May 16, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Phenylephrine | Makes it and tests it | Dr. Reddy's Laboratories Inc. | 43598-172, 43598-199 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 16, 2023 | No problems found | Drug Quality Assurance | — |
| Sep 20, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 11, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 30, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 15, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.