FDA Inspection 683353 — ACTA Laboratories, Inc.
The FDA completed an inspection of ACTA Laboratories, Inc. on Sep 30, 2010 in Foothill Ranch, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Foothill Ranch, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |