FDA Inspection 718434 — Scarguard Labs, LLC
The FDA completed an inspection of Scarguard Labs, LLC on Apr 6, 2011 in Stamford, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Stamford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |