Warning letter
Signature Formulations, LLC: warning letter of Jul 31, 2018
FDA warning letter 545017 · San Francisco District Office
Key facts
| Reference number | 545017 |
|---|---|
| Company | Signature Formulations, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 31, 2018 |
| Posted date | Aug 14, 2018 |
| Issuing office | San Francisco District Office |
| Product type | Drugs |
| CFR sections cited | 201.5, 312.2, 330.1, 341, 201.66(b)(2), 211.22(a), 211.67(b), 211.84(d)(1), 211.84(d)(2), 211.165(a), 211.166(a), 310.545(a)(10)(ii) |
| Inspection city | Phoenix |
| Inspection ZIP | 85043-2729 |
| Inspection start date | Oct 24, 2017 |
| 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: