Amoli Organics Pvt. Limited
Form 483 issued February 12, 2016 · Vapi, India
- Inspection
- Feb 8 – Feb 12, 2016
- Investigator
- Daniel J. Roberts
- Observations
- 12
- Pages
- 5
- FEI number
- 3004810446
In short: On February 12, 2016, FDA issued a Form 483 with 12 observations to Amoli Organics Pvt. Limited in Vapi, Gujarat (FEI 3004810446) after an inspection that ran Feb 8 – Feb 12, 2016. The investigator was Daniel J. Roberts. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 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
Any deviation from established procedures shall be documented and explained. Critical deviations should be investigated, and…
- 02
Data shall be recorded contemporaneously. On February 8, 2016,1 observed maintenance and engineering employee (ww) in…
- 03
All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and…
- 04
All quality-related complaints, whether received orally or in writing, should be recorded and investigated according to…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAmoli Organics Pvt. Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amoli Organics Pvt. Limited?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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 Amoli Organics Pvt. Limited?
Daniel J. Roberts is named on this Form 483, for the inspection of Feb 8 – Feb 12, 2016. Each investigator has a profile showing what they cite most.
When was Amoli Organics Pvt. Limited inspected by FDA?
The inspection ran Feb 8 – Feb 12, 2016, and the Form 483 is dated February 12, 2016.
How do I get the full Form 483 for Amoli Organics Pvt. Limited?
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.