Macleods Pharmaceuticals Limited
Form 483 issued November 1, 2021 · Solan, India
- Investigator
- Dipesh K. Shah
- Observations
- 7
- Pages
- 19
- FEI number
- 3007517881
In short: On November 1, 2021, FDA issued a Form 483 with 7 observations to Macleods Pharmaceuticals Limited in Solan, Himachal Pradesh (FEI 3007517881). The investigator was Dipesh K. Shah. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 6 of 7 observations.
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
Observation 1: scanned text, readable in the full document.
- 02
Your Quality Unit invalidated several OOS investigati root cause for a number of OOS investigations were…
- 03
Written procedures are not established for the cleaning and maintenance of equipment used in the manufacture…
- 04
Investigations of any unexplained discrepancy, a failure of a batch or any of its components to…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
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
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Macleods Pharmaceuticals Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Macleods Pharmaceuticals Limited?
Dipesh K. Shah is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Macleods Pharmaceuticals Limited inspected by FDA?
This Form 483 is dated November 1, 2021.
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.