Warning letter
Professional Compounding Centers of America dba PCCA: warning letter of Jan 27, 2021
FDA warning letter 597638 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 597638 |
|---|---|
| Company | Professional Compounding Centers of America dba PCCA |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Jan 27, 2021 |
| Posted date | Jan 27, 2021 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 299.5(a), 201.1(h)(2) |
| Inspection city | Houston |
| Inspection ZIP | 77099 |
| Inspection start date | Oct 22, 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: