FDA Inspection 1258326 — Certified Laboratories, LLC
The FDA completed an inspection of Certified Laboratories, LLC on Jan 7, 2025 in Burbank, CA. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |