L M Manufacturing Limited
Form 483 issued February 2, 2022 · Northampton, United Kingdom
- Inspection
- Jan 27 – Feb 2, 2022
- Investigator
- Michael A. Charles
- Observations
- 2
- Pages
- 2
- FEI number
- 3015337531
In short: On February 2, 2022, FDA issued a Form 483 with 2 observations to L M Manufacturing Limited in Northampton, United Kingdom (FEI 3015337531) after an inspection that ran Jan 27 – Feb 2, 2022. The investigator was Michael A. Charles. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.110 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. a)…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmL M Manufacturing Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L M Manufacturing Limited?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected L M Manufacturing Limited?
Michael A. Charles is named on this Form 483, for the inspection of Jan 27 – Feb 2, 2022. Each investigator has a profile showing what they cite most.
When was L M Manufacturing Limited inspected by FDA?
The inspection ran Jan 27 – Feb 2, 2022, and the Form 483 is dated February 2, 2022.
How do I get the full Form 483 for L M Manufacturing 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.