FDA Inspection 698924 — Bullet Line LLC
The FDA completed an inspection of Bullet Line LLC on December 6, 2010 in Florence, KY. 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
- December 6, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Florence, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |