Pharmedica USA, LLC
Form 483 issued November 7, 2022 · Phoenix, Arizona
- Inspection
- Nov 1 – Nov 7, 2022
- Investigators
- Joel D. Hustedt· Lillian S. Wu· Youkeun Kim
- Observations
- 5
- Pages
- 4
- FEI number
- 3015269827
In short: On November 7, 2022, FDA issued a Form 483 with 5 observations to Pharmedica USA, LLC in Phoenix, Arizona (FEI 3015269827) after an inspection that ran Nov 1 – Nov 7, 2022. The investigators were Joel D. Hustedt, Lillian S. Wu and Youkeun Kim. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The identity of each component of a ding product is not verified by conducting at least…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmPharmedica USA, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmedica USA, LLC?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmedica USA, LLC?
Joel D. Hustedt, Lillian S. Wu and Youkeun Kim are named on this Form 483, for the inspection of Nov 1 – Nov 7, 2022. Each investigator has a profile showing what they cite most.
When was Pharmedica USA, LLC inspected by FDA?
The inspection ran Nov 1 – Nov 7, 2022, and the Form 483 is dated November 7, 2022.
How do I get the full Form 483 for Pharmedica USA, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.