FDA Inspection 1330666 — Mountainside Medical Equipment, Inc.
The FDA completed an inspection of Mountainside Medical Equipment, Inc. on Aug 12, 2026 in Marcy, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 12, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marcy, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |