FDA Inspection 770125 — Petra Hygienic Systems Int Ltd
The FDA completed an inspection of Petra Hygienic Systems Int Ltd on Feb 9, 2012 in Concord. 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
- Feb 9, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Concord (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |