FDA Inspection 758806 — Thomas Respiratory Health Care
The FDA completed an inspection of Thomas Respiratory Health Care on Dec 16, 2011 in Lebanon, CT. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lebanon, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |