FDA Inspection 781818 — Natural Pharmaceutical Manufacturing LLC
The FDA completed an inspection of Natural Pharmaceutical Manufacturing LLC on May 24, 2012 in Osgood, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Osgood, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 1999 | 21 CFR 211.184(a) | Record information required |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4411 | 21 CFR 211.194(a)(6) | Test results, comparison with standards not included |