FDA Inspection 651241 — Newton Laboratories, Inc.
The FDA completed an inspection of Newton Laboratories, Inc. on Mar 11, 2010 in Conyers, GA. 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
- Mar 11, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conyers, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |