Warning letter
PreMark Health Science, Inc.: warning letter of Dec 18, 2014
FDA warning letter 436111 · Dallas District Office
Key facts
| Reference number | 436111 |
|---|---|
| Company | PreMark Health Science, Inc. |
| Subject | CGMP/Dietary Supplement/Adulterated/Misbranded |
| Issue date | Dec 18, 2014 |
| Posted date | Jan 27, 2015 |
| Issuing office | Dallas District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 111, 111.103, 111.105, 111.210, 111.260, 111.35(b)(2), 111.70(a), 111.70(b), 111.70(d), 111.70(g), 111.205(a), 111.210(a) and 10 more |
| Inspection city | Irving |
| Inspection ZIP | 75038 |
| Inspection start date | Apr 15, 2014 |
| Letter on fda.gov | web.archive.org |
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: