Warning letter
Chemolee Lab Corporation: warning letter of Feb 23, 2016
FDA warning letter 471198 · Dallas District Office
Key facts
| Reference number | 471198 |
|---|---|
| Company | Chemolee Lab Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Feb 23, 2016 |
| Posted date | Feb 23, 2016 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211, 333, 211.67(a), 211.100(a), 211.160(b), 310.545(a)(1) |
| Inspection city | Irving |
| Inspection ZIP | 75061 |
| Inspection start date | Jan 12, 2015 |
| Letter on fda.gov | web.archive.org |
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: