Medical Chemical Corporation
Form 483 issued March 25, 2022 · Torrance, California
- Inspection
- Mar 21 – Mar 25, 2022
- Investigator
- Creighton T. Tuzon
- Observations
- 5
- Pages
- 7
- FEI number
- 2013736
In short: On March 25, 2022, FDA issued a Form 483 with 5 observations to Medical Chemical Corporation in Torrance, California (FEI 2013736) after an inspection that ran Mar 21 – Mar 25, 2022. The investigator was Creighton T. Tuzon. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for design change have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Requirements that must be met by suppliers have…
This inspection in context
Creighton T. Tuzon
6 documents · 2020–2025
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in California.
The firmMedical Chemical Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical Chemical Corporation?
FDA listed 5 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Medical Chemical Corporation?
Creighton T. Tuzon is named on this Form 483, for the inspection of Mar 21 – Mar 25, 2022. Each investigator has a profile showing what they cite most.
When was Medical Chemical Corporation inspected by FDA?
The inspection ran Mar 21 – Mar 25, 2022, and the Form 483 is dated March 25, 2022.
How do I get the full Form 483 for Medical Chemical Corporation?
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.