Pharmedica USA, LLC
FDA inspection history in Phoenix, Arizona, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Phoenix, Arizona.
Cited most
Across all Pharmedica USA observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures1
The complete Pharmedica USA file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Phoenix, Arizona
One warning letter and one Form 483 · 2022 to 2023 · 5 observations
Latest: Warning letter, Apr 28, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-28 | Warning letter Warning letter | Phoenix, Arizona | — | $99 |
| 2022-11-07 | 483 Form 483 | Phoenix, Arizona | 5 | $99 |
Investigators on these documents
FEI number 3015269827 · most recent document Apr 28, 2023
About Pharmedica USA, LLC
How many FDA Form 483s has Pharmedica USA, LLC received?
FDA Intel has 1 Form 483 on file for Pharmedica USA, LLC; the most recent is dated Nov 7, 2022.
When was Pharmedica USA, LLC last inspected by FDA?
The most recent FDA inspection document on file for Pharmedica USA, LLC is a Form 483 dated Nov 7, 2022, for the site in Phoenix, Arizona.
What did FDA cite at Pharmedica USA, LLC?
The regulations cited most in the observations on file for Pharmedica USA, LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has Pharmedica USA, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmedica USA, LLC; the most recent is dated Apr 28, 2023.