1249434
EnviroServe Chemicals Inc. — FEI 3016841297
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dunn, NC (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 |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |