Olon Active Pharmaceutical Ingredients India Private Limited
Form 483 issued May 4, 2023 · Mahad, India
- Inspection
- Apr 27 – May 4, 2023
- Observations
- 10
- Pages
- 12
- FEI number
- 3005983749
In short: On May 4, 2023, FDA issued a Form 483 with 10 observations to Olon Active Pharmaceutical Ingredients India Private Limited in Mahad, Maharashtra (FEI 3005983749) after an inspection that ran Apr 27 – May 4, 2023. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.67 (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
Failure of quality unit to exercise its responsibility to ensure the Active Pharmaceutical Ingredients (APIs) and…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination…
- 04
Buildings used in the manufacturing, processing, packing and holding] of Intermediate APIs and finished APIs materials…
This inspection in context
Questions about this 483
What did FDA find at Olon Active Pharmaceutical Ingredients India Private Limited?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Olon Active Pharmaceutical Ingredients India Private Limited inspected by FDA?
The inspection ran Apr 27 – May 4, 2023, and the Form 483 is dated May 4, 2023.
How do I get the full Form 483 for Olon Active Pharmaceutical Ingredients India 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.