FDA Inspection 1142151 — Dercher Enterprises, Inc.
The FDA completed an inspection of Dercher Enterprises, Inc. on May 4, 2021 in Upper Darby, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 4, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Upper Darby, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |