FDA Inspection 1046262 — DLC Laboratories, Inc
The FDA completed an inspection of DLC Laboratories, Inc on March 30, 2018 in Paramount, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paramount, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |