FDA Inspection 996002 — ABC Compounding Company of Texas, Inc.
The FDA completed an inspection of ABC Compounding Company of Texas, Inc. on November 22, 2016 in Grand Prairie, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 22, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |