PINNACLE LIFE SCIENCE PRIVATE LIMITED
Form 483 issued April 22, 2024 · Solan, India
- Inspection
- Apr 16 – Apr 22, 2024
- Observations
- 5
- Pages
- 5
- FEI number
- 3013744962
In short: On April 22, 2024, FDA issued a Form 483 with 5 observations to PINNACLE LIFE SCIENCE PRIVATE LIMITED in Solan, Himachal Pradesh (FEI 3013744962) after an inspection that ran Apr 16 – Apr 22, 2024. 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
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls governing computer acquired data and/or related systems have not been established. to assure that…
- 02
Routine calibration, inspection, and checking of automatic, mechanical and electronic equipment is not performed according to…
- 03
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at PINNACLE LIFE SCIENCE PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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.
When was PINNACLE LIFE SCIENCE PRIVATE LIMITED inspected by FDA?
The inspection ran Apr 16 – Apr 22, 2024, and the Form 483 is dated April 22, 2024.
How do I get the full Form 483 for PINNACLE LIFE SCIENCE PRIVATE 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.