CTX Lifesciences Private Ltd
Form 483 issued February 16, 2019 · Surat, India
- Inspection
- Feb 11 – Feb 16, 2019
- Investigators
- Lata Mathew· Unnee Ranjan
- Observations
- 4
- Pages
- 8
- FEI number
- 3006254924
In short: On February 16, 2019, FDA issued a Form 483 with 4 observations to CTX Lifesciences Private Ltd in Surat, Gujarat (FEI 3006254924) after an inspection that ran Feb 11 – Feb 16, 2019. The investigators were Lata Mathew and Unnee Ranjan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of quality unit to exercise its responsibility to ensure the Active Pharmaceutical Ingredients (API) manufactured…
- 02
The responsibility of the Quality unit…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Failure to ensure that the contractor for transportation of the API or intermediate knows and follows…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CTX Lifesciences Private Ltd?
FDA listed 4 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected CTX Lifesciences Private Ltd?
Lata Mathew and Unnee Ranjan are named on this Form 483, for the inspection of Feb 11 – Feb 16, 2019. Each investigator has a profile showing what they cite most.
When was CTX Lifesciences Private Ltd inspected by FDA?
The inspection ran Feb 11 – Feb 16, 2019, and the Form 483 is dated February 16, 2019.
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.