Suco Inc
Form 483 issued August 2, 2017 · Silver Spring, Maryland
- Inspection
- Jun 14 – Aug 2, 2017
- Investigators
- Marcellinus D. Dordunoo· Sena G. Dissmeyer
- Observations
- 5
- Pages
- 5
- FEI number
- 3001701624
In short: On August 2, 2017, FDA issued a Form 483 with 5 observations to Suco Inc in Silver Spring, Maryland (FEI 3001701624) after an inspection that ran Jun 14 – Aug 2, 2017. The investigators were Marcellinus D. Dordunoo and Sena G. Dissmeyer. Most observations concern production and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 04
Routine calibration of electronic equipment is not performed according to a written program designed…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Suco Inc?
Marcellinus D. Dordunoo and Sena G. Dissmeyer are named on this Form 483, for the inspection of Jun 14 – Aug 2, 2017. Each investigator has a profile showing what they cite most.
When was Suco Inc inspected by FDA?
The inspection ran Jun 14 – Aug 2, 2017, and the Form 483 is dated August 2, 2017.
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.