Aspen Biopharma Labs Pvt Ltd
Form 483 issued September 21, 2024 · Medchal Malkajgiri, India
- Inspection
- Sep 16 – Sep 21, 2024
- Observations
- 9
- Pages
- 11
- FEI number
- 3012796281
In short: On September 21, 2024, FDA issued a Form 483 with 9 observations to Aspen Biopharma Labs Pvt Ltd in Medchal Malkajgiri, Telangana (FEI 3012796281) after an inspection that ran Sep 16 – Sep 21, 2024. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.100 (2×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm’s documentation practices are inadequate leading…
- 02
The firm lacks a fully functional/operational Quality…
- 03
Control procedures are not established to monitor the output and validate the performance of those manufacturing…
- 04
Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated…
This inspection in context
Questions about this 483
What did FDA find at Aspen Biopharma Labs Pvt Ltd?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Aspen Biopharma Labs Pvt Ltd inspected by FDA?
The inspection ran Sep 16 – Sep 21, 2024, and the Form 483 is dated September 21, 2024.
How do I get the full Form 483 for Aspen Biopharma Labs Pvt Ltd?
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