FDA Inspection 980708 — Howard Phillips LLC dba Phillips Co.
The FDA completed an inspection of Howard Phillips LLC dba Phillips Co. on August 11, 2016 in Millerton, OK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Millerton, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |