FDA Inspection 1163866 — Expert Chemical Analysis, Inc.
The FDA completed an inspection of Expert Chemical Analysis, Inc. on March 7, 2022 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 7, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |