FDA Inspection 859627 — Omega & Delta Co., Inc.
The FDA completed an inspection of Omega & Delta Co., Inc. on Dec 10, 2013 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carolina, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |