Haleon US Holdings LLC
Form 483 issued September 11, 2018 · East Durham, New York
- Inspection
- Aug 30 – Sep 11, 2018
- Investigator
- Rajiv R. Srivastava
- Observations
- 2
- Pages
- 4
- FEI number
- 1314819
In short: On September 11, 2018, FDA issued a Form 483 with 2 observations to Haleon US Holdings LLC in East Durham, New York (FEI 1314819) after an inspection that ran Aug 30 – Sep 11, 2018. The investigator was Rajiv R. Srivastava. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHaleon US Holdings LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Haleon US Holdings LLC?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Haleon US Holdings LLC?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Aug 30 – Sep 11, 2018. Each investigator has a profile showing what they cite most.
When was Haleon US Holdings LLC inspected by FDA?
The inspection ran Aug 30 – Sep 11, 2018, and the Form 483 is dated September 11, 2018.
How do I get the full Form 483 for Haleon US Holdings LLC?
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