Cosco Enterprises, Inc.
Form 483 issued March 26, 2024 · Ridgewood, New York
- Inspection
- Mar 21 – Mar 26, 2024
- Investigator
- Syeda N. Mahazabin
- Observations
- 10
- Pages
- 7
- FEI number
- 2428848
In short: On March 26, 2024, FDA issued a Form 483 with 10 observations to Cosco Enterprises, Inc. in Ridgewood, New York (FEI 2428848) after an inspection that ran Mar 21 – Mar 26, 2024. The investigator was Syeda N. Mahazabin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
Drug product component testing is deficient in that at least one specific test to verify the…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmCosco Enterprises, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosco Enterprises, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cosco Enterprises, Inc.?
Syeda N. Mahazabin is named on this Form 483, for the inspection of Mar 21 – Mar 26, 2024. Each investigator has a profile showing what they cite most.
When was Cosco Enterprises, Inc. inspected by FDA?
The inspection ran Mar 21 – Mar 26, 2024, and the Form 483 is dated March 26, 2024.
How do I get the full Form 483 for Cosco Enterprises, 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.