FDA Inspection 853366 — Pharmasol Corporation
The FDA completed an inspection of Pharmasol Corporation on Oct 30, 2013 in South Easton, MA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- South Easton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |