Macleods Pharmaceuticals Limited
Form 483 issued August 23, 2024 · Pithampur., India
- Inspection
- Aug 20 – Aug 23, 2024
- Observations
- 3
- Pages
- 5
- FEI number
- 3018011011
In short: On August 23, 2024, FDA issued a Form 483 with 3 observations to Macleods Pharmaceuticals Limited in Pithampur., Madhya Pradesh (FEI 3018011011) after an inspection that ran Aug 20 – Aug 23, 2024. Most observations concern quality system.
At a glance
3 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at Macleods Pharmaceuticals Limited?
FDA listed 3 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
When was Macleods Pharmaceuticals Limited inspected by FDA?
The inspection ran Aug 20 – Aug 23, 2024, and the Form 483 is dated August 23, 2024.
How do I get the full Form 483 for Macleods Pharmaceuticals 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.