FDA Inspection 903734 — Apple Homecare Associates, Inc.
The FDA completed an inspection of Apple Homecare Associates, Inc. on November 17, 2014 in Sterling, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 17, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sterling, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |