Warning letter
Petra Hygienic Systems Int Ltd: warning letter of May 7, 2019
FDA warning letter 572769 · Center for Drug Evaluation and Research
Key facts
| Reference number | 572769 |
|---|---|
| Company | Petra Hygienic Systems Int Ltd |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 7, 2019 |
| Posted date | May 14, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.22(d), 211.67(b), 211.84(d)(1), 211.84(d)(2), 211.165(a) |
| Inspection city | Concord |
| Inspection start date | Dec 17, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: