Surmasis Pharmaceutical, LLC
Form 483 issued December 2, 2021 · Des Moines, Iowa
- Observations
- 5
- Pages
- 5
- FEI number
- 1930027
In short: On December 2, 2021, FDA issued a Form 483 with 5 observations to Surmasis Pharmaceutical, LLC in Des Moines, Iowa (FEI 1930027). Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
3 of 5 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (2×) · 820.90 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation activities and results have…
- 02
Process control procedures that describe any process controls necessary to ensure eonfermanceto specifications compliance to reference…
- 03
Documentation of rework and reevaluation activities does not include a determination of whether there has been…
- 04
Procedures have not been established to control product that does not…
This inspection in context
Questions about this 483
What did FDA find at Surmasis Pharmaceutical, LLC?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
When was Surmasis Pharmaceutical, LLC inspected by FDA?
This Form 483 is dated December 2, 2021.
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.