Warning letter
ITL Asia Pacific Sdn Bhd: warning letter of Sep 25, 2019
FDA warning letter 590380 · OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality
Key facts
| Reference number | 590380 |
|---|---|
| Company | ITL Asia Pacific Sdn Bhd |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Sep 25, 2019 |
| Posted date | Mar 3, 2020 |
| Issuing office | OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820 |
| Inspection city | Batu Gajah |
| Inspection start date | May 27, 2019 |
| 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: