FDA Inspection 1051973 — Canton Laboratories LLC
The FDA completed an inspection of Canton Laboratories LLC on May 11, 2018 in Alpharetta, GA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 3641 | 21 CFR 211.204 | Record information inclusions |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |