FDA Inspection 866493 — Coats Aloe International, Inc.
The FDA completed an inspection of Coats Aloe International, Inc. on March 4, 2014 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |