FDA Inspection 750933 — Straight Arrow Products, Inc.
The FDA completed an inspection of Straight Arrow Products, Inc. on October 17, 2011 in Bethlehem, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bethlehem, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |