Zolberg Corporation
Form 483 issued December 7, 2023 · Bangcal, Philippines
- Inspection
- Dec 4 – Dec 7, 2023
- Investigator
- Nibin Varghese
- Observations
- 3
- Pages
- 2
- FEI number
- 3004200690
In short: On December 7, 2023, FDA issued a Form 483 with 3 observations to Zolberg Corporation in Bangcal, Cavite (FEI 3004200690) after an inspection that ran Dec 4 – Dec 7, 2023. The investigator was Nibin Varghese. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
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
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
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 firmZolberg Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zolberg Corporation?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Zolberg Corporation?
Nibin Varghese is named on this Form 483, for the inspection of Dec 4 – Dec 7, 2023. Each investigator has a profile showing what they cite most.
When was Zolberg Corporation inspected by FDA?
The inspection ran Dec 4 – Dec 7, 2023, and the Form 483 is dated December 7, 2023.
How do I get the full Form 483 for Zolberg 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.