FDA Inspection 629664 — Apozeal Pharmaceuticals Inc.
The FDA completed an inspection of Apozeal Pharmaceuticals Inc. on October 27, 2009 in Levittown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 27, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Levittown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |