FDA Inspection 863543 — Global Life Technologies Corporation
The FDA completed an inspection of Global Life Technologies Corporation on Feb 6, 2014 in Chevy Chase, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 6, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chevy Chase, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4383 | 21 CFR 211.198(b)(1) | Written complaint record must include |