1177190
Profounda Inc — FEI 3011873350
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 9, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4576 | 21 CFR 211.192 | No written record of investigation |