FDA inspection
Petra Hygienic Systems Int Ltd: FDA inspection ending Dec 21, 2018
FDA inspection 1075197 · Official Action Indicated (OAI) · Concord
Key facts
| Inspection ID | 1075197 |
|---|---|
| Firm | Petra Hygienic Systems Int Ltd |
| FEI number | 3002869527 |
| Address | 86 Moyal Crt |
| City | Concord |
| Country | Canada |
| Fiscal year | 2019 |
| Inspection end date | Dec 21, 2018 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 572769 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data