Macleods Pharmaceuticals Limited
Form 483 issued May 26, 2023 · Daman, India
- Inspection
- May 22 – May 26, 2023
- Investigator
- Teresa I. Navas
- Observations
- 1
- Pages
- 2
- FEI number
- 3006363714
In short: On May 26, 2023, FDA issued a Form 483 with 1 observation to Macleods Pharmaceuticals Limited in Daman, Daman (FEI 3006363714) after an inspection that ran May 22 – May 26, 2023. The investigator was Teresa I. Navas. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMacleods Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Macleods Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Macleods Pharmaceuticals Limited?
Teresa I. Navas is named on this Form 483, for the inspection of May 22 – May 26, 2023. Each investigator has a profile showing what they cite most.
When was Macleods Pharmaceuticals Limited inspected by FDA?
The inspection ran May 22 – May 26, 2023, and the Form 483 is dated May 26, 2023.
How do I get the full Form 483 for Macleods Pharmaceuticals Limited?
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