CTX Lifesciences Private Ltd
Form 483 issued February 18, 2016 · Surat, India
- Inspection
- Feb 15 – Feb 18, 2016
- Investigator
- Massoud Motamed
- Observations
- 6
- Pages
- 7
- FEI number
- 3006254924
In short: On February 18, 2016, FDA issued a Form 483 with 6 observations to CTX Lifesciences Private Ltd in Surat, Gujarat (FEI 3006254924) after an inspection that ran Feb 15 – Feb 18, 2016. The investigator was Massoud Motamed. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Building, equipment and supply lines are not maintained in an adequate condition ensure the API's identity…
- 02
“Critical process parameters” are not…
- 03
APIs are transferred container closures without and assigned expiry dates without…
- 04
The Quality Department lacks the authority to reject…
This inspection in context
Massoud Motamed
20 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
The firmCTX Lifesciences Private Ltd history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CTX Lifesciences Private Ltd?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected CTX Lifesciences Private Ltd?
Massoud Motamed is named on this Form 483, for the inspection of Feb 15 – Feb 18, 2016. Each investigator has a profile showing what they cite most.
When was CTX Lifesciences Private Ltd inspected by FDA?
The inspection ran Feb 15 – Feb 18, 2016, and the Form 483 is dated February 18, 2016.
How do I get the full Form 483 for CTX Lifesciences Private Ltd?
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.