Suco Inc
Form 483 issued February 25, 2024 · Silver Spring, Maryland
- Inspection
- Feb 16 – Feb 25, 2024
- Investigator
- Michael O. Idowu
- Observations
- 4
- Pages
- 5
- FEI number
- 3001701624
In short: On February 25, 2024, FDA issued a Form 483 with 4 observations to Suco Inc in Silver Spring, Maryland (FEI 3001701624) after an inspection that ran Feb 16 – Feb 25, 2024. The investigator was Michael O. Idowu. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
The procedures for the annual quality standards record evaluation are deficient in that they do not…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Michael O. Idowu
4 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
The firmSuco Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Suco Inc?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Suco Inc?
Michael O. Idowu is named on this Form 483, for the inspection of Feb 16 – Feb 25, 2024. Each investigator has a profile showing what they cite most.
When was Suco Inc inspected by FDA?
The inspection ran Feb 16 – Feb 25, 2024, and the Form 483 is dated February 25, 2024.
How do I get the full Form 483 for Suco Inc?
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.