Surmasis Pharmaceutical, LLC
Form 483 issued March 19, 2020 · Des Moines, Iowa
- Inspection
- Mar 9 – Mar 19, 2020
- Investigators
- Michele L. Glendenning· Peng Zhou
- Observations
- 3
- Pages
- 4
- FEI number
- 3011596846
In short: On March 19, 2020, FDA issued a Form 483 with 3 observations to Surmasis Pharmaceutical, LLC in Des Moines, Iowa (FEI 3011596846) after an inspection that ran Mar 9 – Mar 19, 2020. The investigators were Michele L. Glendenning and Peng Zhou. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to reject all components, in process…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
The firmSurmasis Pharmaceutical, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Surmasis Pharmaceutical, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Surmasis Pharmaceutical, LLC?
Michele L. Glendenning and Peng Zhou are named on this Form 483, for the inspection of Mar 9 – Mar 19, 2020. Each investigator has a profile showing what they cite most.
When was Surmasis Pharmaceutical, LLC inspected by FDA?
The inspection ran Mar 9 – Mar 19, 2020, and the Form 483 is dated March 19, 2020.
How do I get the full Form 483 for Surmasis Pharmaceutical, 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.