FDA Inspection 1119892 — TRUECARE BIOMEDIX
The FDA completed an inspection of TRUECARE BIOMEDIX on March 6, 2020 in Balasinor. 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
- March 6, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Balasinor (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |