Warning letter
Dercher Enterprises, Inc., DBA Gordon Laboratories: warning letter of Sep 13, 2019
FDA warning letter 580346 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 580346 |
|---|---|
| Company | Dercher Enterprises, Inc., DBA Gordon Laboratories |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 13, 2019 |
| Posted date | Dec 17, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 201.5, 201.128, 211.34, 211.192, 310.548, 201.100(c)(2), 211.22(a), 211.22(d), 211.165(b) |
| Inspection city | Upper Darby |
| Inspection ZIP | 19082-2408 |
| Inspection start date | Mar 7, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: