Warning letter
Spectrum Laboratory Products, Inc.: warning letter of Jul 31, 2019
FDA warning letter 579958 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 579958 |
|---|---|
| Company | Spectrum Laboratory Products, Inc. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Jul 31, 2019 |
| Posted date | Aug 13, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 201.1(h)(2), 207.17, 207 |
| Inspection city | New Brunswick |
| Inspection ZIP | 08901 |
| Inspection start date | Feb 19, 2019 |
| 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: