FDA Inspection 724336 — Sage Pharmaceuticals, Inc.
The FDA completed an inspection of Sage Pharmaceuticals, Inc. on May 6, 2011 in Shreveport, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Shreveport, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |