PF Consumer Healthcare 1 LLC
Form 483 issued April 1, 2019 · Albany, Georgia
- Inspection
- Feb 25 – Apr 1, 2019
- Investigators
- Dawn M. Braswell· Joshua J. Silvestri· Lisa A. Warner
- Observations
- 2
- Pages
- 15
In short: On April 1, 2019, FDA issued a Form 483 with 2 observations to PF Consumer Healthcare 1 LLC in Albany, Georgia after an inspection that ran Feb 25 – Apr 1, 2019. The investigators were Dawn M. Braswell, Joshua J. Silvestri and Lisa A. Warner. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Dawn M. Braswell
4 documents · 2019–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Georgia.
The firmPF Consumer Healthcare 1 LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PF Consumer Healthcare 1 LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected PF Consumer Healthcare 1 LLC?
Dawn M. Braswell, Joshua J. Silvestri and Lisa A. Warner are named on this Form 483, for the inspection of Feb 25 – Apr 1, 2019. Each investigator has a profile showing what they cite most.
When was PF Consumer Healthcare 1 LLC inspected by FDA?
The inspection ran Feb 25 – Apr 1, 2019, and the Form 483 is dated April 1, 2019.
How do I get the full Form 483 for PF Consumer Healthcare 1 LLC?
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.