FDA Inspection 928484 — SGS Chemical Solutions Laboratories Inc.
The FDA completed an inspection of SGS Chemical Solutions Laboratories Inc. on June 3, 2015 in Harrisburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 3, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Harrisburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |