Welch, Holme & Clark Co., Inc
Form 483 issued July 10, 2024 · Newark, New Jersey
- Inspection
- Jul 1 – Jul 10, 2024
- Investigator
- Victoria Spivak
- Observations
- 3
- Pages
- 3
- FEI number
- 2211876
In short: On July 10, 2024, FDA issued a Form 483 with 3 observations to Welch, Holme & Clark Co., Inc in Newark, New Jersey (FEI 2211876) after an inspection that ran Jul 1 – Jul 10, 2024. The investigator was Victoria Spivak. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
This inspection in context
Victoria Spivak
8 documents · 2023–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmWelch, Holme & Clark Co., Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Welch, Holme & Clark Co., Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Welch, Holme & Clark Co., Inc?
Victoria Spivak is named on this Form 483, for the inspection of Jul 1 – Jul 10, 2024. Each investigator has a profile showing what they cite most.
When was Welch, Holme & Clark Co., Inc inspected by FDA?
The inspection ran Jul 1 – Jul 10, 2024, and the Form 483 is dated July 10, 2024.
How do I get the full Form 483 for Welch, Holme & Clark Co., Inc?
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.