Inga Pharmaceuticals
Form 483 issued June 16, 2017 · Chennai, India
- Inspection
- Jun 12 – Jun 16, 2017
- Investigator
- Ariel Cruz Figueroa
- Observations
- 5
- Pages
- 3
- FEI number
- 3008327597
In short: On June 16, 2017, FDA issued a Form 483 with 5 observations to Inga Pharmaceuticals in Chennai, Tamil Nadu (FEI 3008327597) after an inspection that ran Jun 12 – Jun 16, 2017. The investigator was Ariel Cruz Figueroa. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.68 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The procedure for calibration…
- 02
There is no procedure that de: be the issuance…
- 03
The respons bilities and procedures of the quality unit…
- 04
There is no frequency established to perform the sanitization…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmInga Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Inga Pharmaceuticals?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Inga Pharmaceuticals?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Jun 12 – Jun 16, 2017. Each investigator has a profile showing what they cite most.
When was Inga Pharmaceuticals inspected by FDA?
The inspection ran Jun 12 – Jun 16, 2017, and the Form 483 is dated June 16, 2017.
How do I get the full Form 483 for Inga Pharmaceuticals?
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.