FDA Inspection 746108 — Pure Source, LLC
The FDA completed an inspection of Pure Source, LLC on Sep 22, 2011 in Doral, FL. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |