Carma Laboratories, Inc.
Form 483 issued November 14, 2023 · Franklin, Wisconsin
- Inspection
- Nov 9 – Nov 14, 2023
- Investigator
- Nibin Varghese
- Observations
- 6
- Pages
- 6
- FEI number
- 2121163
In short: On November 14, 2023, FDA issued a Form 483 with 6 observations to Carma Laboratories, Inc. in Franklin, Wisconsin (FEI 2121163) after an inspection that ran Nov 9 – Nov 14, 2023. The investigator was Nibin Varghese. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Nibin Varghese
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmCarma Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carma Laboratories, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Carma Laboratories, Inc.?
Nibin Varghese is named on this Form 483, for the inspection of Nov 9 – Nov 14, 2023. Each investigator has a profile showing what they cite most.
When was Carma Laboratories, Inc. inspected by FDA?
The inspection ran Nov 9 – Nov 14, 2023, and the Form 483 is dated November 14, 2023.
How do I get the full Form 483 for Carma Laboratories, 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.