FDA Inspection 804072 — Linde Gas Equipment Inc.
The FDA completed an inspection of Linde Gas Equipment Inc. on Sep 14, 2012 in Albuquerque, NM. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 14, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |