CiplaLtd
Form 483 issued March 20, 2019 · Pune, India
- Inspection
- Mar 11 – Mar 20, 2019
- Investigators
- Angela E. Glenn· Cheryl Clausen· Vani Mathur Richards
- Observations
- 18
- Pages
- 15
- FEI number
- 3002806702
In short: On March 20, 2019, FDA issued a Form 483 with 18 observations to CiplaLtd in Pune, Maharashtra (FEI 3002806702) after an inspection that ran Mar 11 – Mar 20, 2019. The investigators were Angela E. Glenn, Cheryl Clausen and Vani Mathur Richards. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You do not have an established, documented, and implemented effective system for managing quality that involves…
- 02
You do not always adequately document and explain deviations…
- 03
You do not have a quality unit involved in all quality related matters including approving changes…
- 04
Training is not always regularly conducted by a qualified individual covering, at a minimum the particular…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmCiplaLtd history
All 4 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 CiplaLtd?
FDA listed 18 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected CiplaLtd?
Angela E. Glenn, Cheryl Clausen and Vani Mathur Richards are named on this Form 483, for the inspection of Mar 11 – Mar 20, 2019. Each investigator has a profile showing what they cite most.
When was CiplaLtd inspected by FDA?
The inspection ran Mar 11 – Mar 20, 2019, and the Form 483 is dated March 20, 2019.
How do I get the full Form 483 for CiplaLtd?
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.