FDA Inspection 1019255 — Holly Oak Chemical, Inc.
The FDA completed an inspection of Holly Oak Chemical, Inc. on April 25, 2017 in Fountain Inn, SC. 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
- April 25, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fountain Inn, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 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 |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |