FDA Inspection 1057782 — Izeen Pharma Inc
The FDA completed an inspection of Izeen Pharma Inc on July 3, 2018 in Frederick, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 3, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |