FDA Inspection 814862 — Omega Packaging Corp
The FDA completed an inspection of Omega Packaging Corp on Jan 28, 2013 in Totowa, NJ. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 28, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Totowa, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |