Warning letter
Apollo Care: warning letter of Mar 20, 2019
FDA warning letter 574756 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 574756 |
|---|---|
| Company | Apollo Care |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Mar 20, 2019 |
| Posted date | Apr 9, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 210.1(b), 201.115, 211.188, 211.192, 200.10(b), 211.22(d), 211.25(a), 211.42(c)(10)(iv), 211.56(a), 211.68(a), 211.80(a), 211.113(b) |
| Inspection city | Columbia |
| Inspection ZIP | 65202 |
| Inspection start date | Feb 12, 2018 |
| 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: