Cosmax Usa, Corporation
Form 483 issued September 20, 2017 · Carteret, New Jersey
- Inspection
- Sep 14 – Sep 20, 2017
- Investigator
- Tamil Arasu
- Observations
- 4
- Pages
- 4
- FEI number
- 3002679704
In short: On September 20, 2017, FDA issued a Form 483 with 4 observations to Cosmax Usa, Corporation in Carteret, New Jersey (FEI 3002679704) after an inspection that ran Sep 14 – Sep 20, 2017. The investigator was Tamil Arasu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
- 04
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCosmax Usa, Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmax Usa, Corporation?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Cosmax Usa, Corporation?
Tamil Arasu is named on this Form 483, for the inspection of Sep 14 – Sep 20, 2017. Each investigator has a profile showing what they cite most.
When was Cosmax Usa, Corporation inspected by FDA?
The inspection ran Sep 14 – Sep 20, 2017, and the Form 483 is dated September 20, 2017.
How do I get the full Form 483 for Cosmax Usa, Corporation?
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.