FDA Inspection 949048 — Preferred Pharmaceuticals, Inc.
The FDA completed an inspection of Preferred Pharmaceuticals, Inc. on October 29, 2015 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 3641 | 21 CFR 211.204 | Record information inclusions |