FDA Inspection 1046486 — Newton Laboratories, Inc.
The FDA completed an inspection of Newton Laboratories, Inc. on March 30, 2018 in Conyers, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Conyers, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |