FDA Inspection 747521 — Allcare Medical
The FDA completed an inspection of Allcare Medical on October 12, 2011 in North Brunswick, NJ. 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
- October 12, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |