LEC Custom Products, Inc.
Form 483 issued September 2, 2022 · Mississauga, Canada
- Inspection
- Aug 29 – Sep 2, 2022
- Investigator
- Camerson E. Moore
- Observations
- 7
- Pages
- 6
- FEI number
- 3012665392
In short: On September 2, 2022, FDA issued a Form 483 with 7 observations to LEC Custom Products, Inc. in Mississauga, Ontario (FEI 3012665392) after an inspection that ran Aug 29 – Sep 2, 2022. The investigator was Camerson E. Moore. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
The master production and control records are deficient in that they do not include complete manufacturing…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmLEC Custom Products, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.186(b)(9)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LEC Custom Products, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected LEC Custom Products, Inc.?
Camerson E. Moore is named on this Form 483, for the inspection of Aug 29 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was LEC Custom Products, Inc. inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
How do I get the full Form 483 for LEC Custom Products, Inc.?
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.