FDA Inspection 765470 — Rockline Industries, Inc
The FDA completed an inspection of Rockline Industries, Inc on January 30, 2012 in Sheboygan, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sheboygan, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4576 | 21 CFR 211.192 | No written record of investigation |