Warning letter
Polymer Technology Systems, Inc.: warning letter of Jul 31, 2019
FDA warning letter 576934 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 576934 |
|---|---|
| Company | Polymer Technology Systems, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 31, 2019 |
| Posted date | Aug 20, 2019 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 806, 806.10, 862.3220, 803.17(a)(1), 803.17(a)(3), 803.17(b), 803.50(a)(2), 862.9(a), 862.9(c)(9) and 3 more |
| Inspection city | Whitestown |
| Inspection ZIP | 46075 |
| Inspection start date | Jan 28, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: