Master Paints & Chemical Corp
Form 483 issued October 17, 2023 · Guayanilla, Puerto Rico
- Inspection
- Oct 11 – Oct 17, 2023
- Investigator
- Ariel Cruz Figueroa
- Observations
- 7
- Pages
- 5
- FEI number
- 3016668136
In short: On October 17, 2023, FDA issued a Form 483 with 7 observations to Master Paints & Chemical Corp in Guayanilla, Puerto Rico (FEI 3016668136) after an inspection that ran Oct 11 – Oct 17, 2023. The investigator was Ariel Cruz Figueroa. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and materials account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
Determinations of conformance to appropriate written specifications for acceptance are not made and…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMaster Paints & Chemical Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Master Paints & Chemical Corp?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, materials and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Master Paints & Chemical Corp?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Oct 11 – Oct 17, 2023. Each investigator has a profile showing what they cite most.
When was Master Paints & Chemical Corp inspected by FDA?
The inspection ran Oct 11 – Oct 17, 2023, and the Form 483 is dated October 17, 2023.
How do I get the full Form 483 for Master Paints & Chemical Corp?
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.