Surmasis Pharmaceutical, LLC
FDA inspection history in Des Moines, Iowa, 2018 to 2021
- 2
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2018: one close-out letter; 2020: one close-out letter and one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Two close-out letters and two Form 483s, at Des Moines, Iowa.
- 2021The longest 483 on file: 5 observations over 5 pages at Des Moines, Iowa.
Cited most
Across all Surmasis Pharmaceutical observations on file
- 21 CFR 820.70Production and process controls2
- 21 CFR 820.90Nonconforming product2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Surmasis Pharmaceutical file.
All 4 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
Des Moines, Iowa
Two Form 483s and two close-out letters · 2018 to 2021 · 8 observations
Latest: Form 483, Dec 2, 2021 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-02 | 483 Form 483 | Des Moines, Iowa | 5 | $99 |
| 2020-06-22 | Close-out Close-out letter | Des Moines, Iowa | — | $99 |
| 2020-03-19 | 483 Form 483 | Des Moines, Iowa | 3 | $99 |
| 2018-11-06 | Close-out Close-out letter | Des Moines, Iowa | — | $99 |
Investigators on these documents
FEI number 3011596846 · most recent document Dec 2, 2021
About Surmasis Pharmaceutical, LLC
How many FDA Form 483s has Surmasis Pharmaceutical, LLC received?
FDA Intel has 2 Form 483s on file for Surmasis Pharmaceutical, LLC; the most recent is dated Dec 2, 2021.
When was Surmasis Pharmaceutical, LLC last inspected by FDA?
The most recent FDA inspection document on file for Surmasis Pharmaceutical, LLC is a Form 483 dated Dec 2, 2021, for the site in Des Moines, Iowa.
What did FDA cite at Surmasis Pharmaceutical, LLC?
The regulations cited most in the observations on file for Surmasis Pharmaceutical, LLC are 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 820.90 (Nonconforming product), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.