Macleods Pharmaceuticals Limited
Form 483 issued October 20, 2023 · Solan, India
- Inspection
- Oct 13 – Oct 20, 2023
- Investigator
- Muna Algharibeh
- Observations
- 8
- Pages
- 4
- FEI number
- 3007517881
In short: On October 20, 2023, FDA issued a Form 483 with 8 observations to Macleods Pharmaceuticals Limited in Solan, Himachal Pradesh (FEI 3007517881) after an inspection that ran Oct 13 – Oct 20, 2023. The investigator was Muna Algharibeh. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmMacleods Pharmaceuticals Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Macleods Pharmaceuticals Limited?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Macleods Pharmaceuticals Limited?
Muna Algharibeh is named on this Form 483, for the inspection of Oct 13 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was Macleods Pharmaceuticals Limited inspected by FDA?
The inspection ran Oct 13 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
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.