CosMedical. Technologies, LLC
Form 483 issued July 7, 2025 · Davie, Florida
- Inspection
- Jun 30 – Jul 7, 2025
- Investigators
- Michael Z. Weigman· Mickell Smith· Ronda R. Loyd Jones
- Observations
- 6
- Pages
- 8
- FEI number
- 3007481323
In short: On July 7, 2025, FDA issued a Form 483 with 6 observations to CosMedical. Technologies, LLC in Davie, Florida (FEI 3007481323) after an inspection that ran Jun 30 – Jul 7, 2025. The investigators were Michael Z. Weigman, Mickell Smith and Ronda R. Loyd Jones. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed and packed…
- 04
The responsibilities and procedures applicable to the quality control unit are not in writing…
This inspection in context
Michael Z. Weigman
6 documents · 2025–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmCosMedical. Technologies, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CosMedical. Technologies, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected CosMedical. Technologies, LLC?
Michael Z. Weigman, Mickell Smith and Ronda R. Loyd Jones are named on this Form 483, for the inspection of Jun 30 – Jul 7, 2025. Each investigator has a profile showing what they cite most.
When was CosMedical. Technologies, LLC inspected by FDA?
The inspection ran Jun 30 – Jul 7, 2025, and the Form 483 is dated July 7, 2025.
How do I get the full Form 483 for CosMedical. Technologies, LLC?
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.