FDA Inspection 1254756 — Noble Panacea Labs, Inc.
The FDA completed an inspection of Noble Panacea Labs, Inc. on Nov 8, 2024 in Irvine, 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 8, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3606 | 21 CFR 211.160(b)(1) | Retesting |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |