Warning letter
Spectrum Laboratory Products: warning letter of Jun 4, 2019
FDA warning letter 573311 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 573311 |
|---|---|
| Company | Spectrum Laboratory Products |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Jun 4, 2019 |
| Posted date | Jun 11, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 201.1(h)(2), 207.17 |
| Inspection city | Gardena |
| Inspection ZIP | 90248 |
| Inspection start date | Nov 8, 2018 |
| Letter on fda.gov | fda.gov |
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: