Madcar A Division of Century Direct
Form 483 issued December 20, 2023 · Islandia, New York
- Inspection
- Dec 15 – Dec 20, 2023
- Investigator
- Amatul H. Marium
- Observations
- 5
- Pages
- 5
- FEI number
- 1000119754
In short: On December 20, 2023, FDA issued a Form 483 with 5 observations to Madcar A Division of Century Direct in Islandia, New York (FEI 1000119754) after an inspection that ran Dec 15 – Dec 20, 2023. The investigator was Amatul H. Marium. Most observations concern production and packaging & labeling.
At a glance
3 of 5 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Strict control is not exercised over labeling issued for use in…
- 02
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 03
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 04
Deviations from written production and process control…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmMadcar A Division of Century Direct history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.125(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Madcar A Division of Century Direct?
FDA listed 5 observations on this Form 483, mostly about production, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Madcar A Division of Century Direct?
Amatul H. Marium is named on this Form 483, for the inspection of Dec 15 – Dec 20, 2023. Each investigator has a profile showing what they cite most.
When was Madcar A Division of Century Direct inspected by FDA?
The inspection ran Dec 15 – Dec 20, 2023, and the Form 483 is dated December 20, 2023.
How do I get the full Form 483 for Madcar A Division of Century Direct?
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.