Warning letter
Pharmaceutical Laboratories and Consultants, Inc.: warning letter of Aug 29, 2018
FDA warning letter 540675 · Detroit District Office
Key facts
| Reference number | 540675 |
|---|---|
| Company | Pharmaceutical Laboratories and Consultants, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 29, 2018 |
| Posted date | Sep 18, 2018 |
| Issuing office | Detroit District Office |
| Product type | Drugs |
| CFR sections cited | 211.194(a), 211.34, 211.63, 211.25(a), 211.160(b) |
| Inspection city | Addison |
| Inspection ZIP | 60101 |
| Inspection start date | Sep 18, 2017 |
| 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: