FDA Inspection 1222135 — Morgan Gallacher
The FDA completed an inspection of Morgan Gallacher on Oct 26, 2023 in Santa Fe Springs, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 26, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Fe Springs, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |