FDA Inspection 1101992 — C-Care, LLC
The FDA completed an inspection of C-Care, LLC on September 16, 2019 in Linthicum Heights, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Linthicum Heights, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |