Warning letter
Tailor Made Compounding LLC: warning letter of Apr 1, 2020
FDA warning letter 594743 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 594743 |
|---|---|
| Company | Tailor Made Compounding LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Apr 1, 2020 |
| Posted date | May 5, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 210.1(b), 211.84(d)(1), 211.113(b), 201.115, 211.192, 200.10(b), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.68(a) |
| Inspection city | Nicholasville |
| Inspection ZIP | 40356 |
| Inspection start date | Aug 20, 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: