FDA Inspection 1066751 — Avara Pharmaceutical Technologies, Inc.
The FDA completed an inspection of Avara Pharmaceutical Technologies, Inc. on Sep 26, 2018 in Norman, 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)
- End Date
- Sep 26, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Norman, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |