CMIC CMO USA CORPORATION
Form 483 issued May 4, 2021 · Cranbury, New Jersey
- Inspection
- May 4, 2021
- Investigators
- Ankur C. Patel· Russell J. Glapion
- Observations
- 2
- Pages
- 3
- FEI number
- 3001237056
In short: On May 4, 2021, FDA issued a Form 483 with 2 observations to CMIC CMO USA CORPORATION in Cranbury, New Jersey (FEI 3001237056) after an inspection that ran May 4, 2021. The investigators were Ankur C. Patel and Russell J. Glapion. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Time limits are not established when appropriate for the completion of each production phase to assure…
- 02
Records are not kept for the maintenance and inspection of equipment. Electronic records are used, but…
This inspection in context
Ankur C. Patel
9 documents · 2021–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmCMIC CMO USA CORPORATION history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.111
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CMIC CMO USA CORPORATION?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected CMIC CMO USA CORPORATION?
Ankur C. Patel and Russell J. Glapion are named on this Form 483, for the inspection of May 4, 2021. Each investigator has a profile showing what they cite most.
When was CMIC CMO USA CORPORATION inspected by FDA?
The inspection ran May 4, 2021, and the Form 483 is dated May 4, 2021.
How do I get the full Form 483 for CMIC CMO 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.