FDA Inspection 987780 — Howard Phillips LLC dba Phillips Co.
The FDA completed an inspection of Howard Phillips LLC dba Phillips Co. on October 7, 2016 in Millerton, OK. 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
- October 7, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Millerton, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |