Apotex Research Private Limited
Form 483 issued November 17, 2017 · Bengaluru, India
- Observations
- 9
- Pages
- 9
- FEI number
- 3006076314
In short: On November 17, 2017, FDA issued a Form 483 with 9 observations to Apotex Research Private Limited in Bengaluru, Karnataka (FEI 3006076314). Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.67 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 03
For each batch of drug product, there shall be appropriate final specifications…
- 04
Production equipment is not maintained at an appropriate interval to prevent malfunctions that could alter the…
This inspection in context
Questions about this 483
What did FDA find at Apotex Research Private Limited?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Apotex Research Private Limited inspected by FDA?
This Form 483 is dated November 17, 2017.
How do I get the full Form 483 for Apotex Research 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.