LiquidCapsule Manufacturing
Form 483 issued February 9, 2024 · Tampa, Florida
- Inspection
- Feb 5 – Feb 9, 2024
- Investigator
- Suzanne N. Vallez
- Observations
- 5
- Pages
- 6
- FEI number
- 3006676534
In short: On February 9, 2024, FDA issued a Form 483 with 5 observations to LiquidCapsule Manufacturing in Tampa, Florida (FEI 3006676534) after an inspection that ran Feb 5 – Feb 9, 2024. The investigator was Suzanne N. Vallez. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Yom firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Acceptance criteria for the sampling and testing coriducted by the qualih< control imit is not adequate…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Suzanne N. Vallez
6 documents · 2022–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmLiquidCapsule Manufacturing history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LiquidCapsule Manufacturing?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected LiquidCapsule Manufacturing?
Suzanne N. Vallez is named on this Form 483, for the inspection of Feb 5 – Feb 9, 2024. Each investigator has a profile showing what they cite most.
When was LiquidCapsule Manufacturing inspected by FDA?
The inspection ran Feb 5 – Feb 9, 2024, and the Form 483 is dated February 9, 2024.
How do I get the full Form 483 for LiquidCapsule Manufacturing?
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.