Intermed
Form 483 issued March 17, 2023 · Chennai, India
- Inspection
- Mar 13 – Mar 17, 2023
- Investigators
- Alan L. Truong· Joan M. Cantellops Figueroa
- Observations
- 6
- Pages
- 6
- FEI number
- 3005202412
In short: On March 17, 2023, FDA issued a Form 483 with 6 observations to Intermed in Chennai, Tamil Nadu (FEI 3005202412) after an inspection that ran Mar 13 – Mar 17, 2023. The investigators were Alan L. Truong and Joan M. Cantellops Figueroa. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 02
Verification of the suitability of the testing methods is deficient in that they are not documented…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmIntermed history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intermed?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Intermed?
Alan L. Truong and Joan M. Cantellops Figueroa are named on this Form 483, for the inspection of Mar 13 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was Intermed inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
How do I get the full Form 483 for Intermed?
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.