FDA Inspection 1043530 — Sklar BOV Solutions, Inc
The FDA completed an inspection of Sklar BOV Solutions, Inc on Mar 7, 2018 in Statesville, NC. 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
- Mar 7, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Statesville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4576 | 21 CFR 211.192 | No written record of investigation |