AMOL PHARMACEUTICALS PRIVATE LIMITED
Form 483 issued September 13, 2019 · Jaipur, India
- Inspection
- Sep 9 – Sep 13, 2019
- Investigator
- Unnee Ranjan
- Observations
- 1
- Pages
- 2
- FEI number
- 3003925108
In short: On September 13, 2019, FDA issued a Form 483 with 1 observation to AMOL PHARMACEUTICALS PRIVATE LIMITED in Jaipur, Rajasthan (FEI 3003925108) after an inspection that ran Sep 9 – Sep 13, 2019. The investigator was Unnee Ranjan. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmAMOL PHARMACEUTICALS PRIVATE LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AMOL PHARMACEUTICALS PRIVATE LIMITED?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected AMOL PHARMACEUTICALS PRIVATE LIMITED?
Unnee Ranjan is named on this Form 483, for the inspection of Sep 9 – Sep 13, 2019. Each investigator has a profile showing what they cite most.
When was AMOL PHARMACEUTICALS PRIVATE LIMITED inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2019, and the Form 483 is dated September 13, 2019.
How do I get the full Form 483 for AMOL PHARMACEUTICALS PRIVATE LIMITED?
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