FDA Inspection 1003842 — Omega & Delta Co., Inc.
The FDA completed an inspection of Omega & Delta Co., Inc. on Feb 7, 2017 in Carolina, PR. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carolina, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |