Private Label Productions LLC
Form 483 issued February 9, 2024 · Bonita Springs, Florida
- Inspection
- Feb 6 – Feb 9, 2024
- Investigator
- Nydia E. Colon
- Observations
- 2
- Pages
- 3
- FEI number
- 3016616658
In short: On February 9, 2024, FDA issued a Form 483 with 2 observations to Private Label Productions LLC in Bonita Springs, Florida (FEI 3016616658) after an inspection that ran Feb 6 – Feb 9, 2024. The investigator was Nydia E. Colon. Most observations concern management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
2 of 2 observations on this 483 concern management controls.
Most cited: 21 CFR 820.20(c) (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality…
- 02
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
This inspection in context
Nydia E. Colon
4 documents · 2019–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPrivate Label Productions LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Private Label Productions LLC?
FDA listed 2 observations on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Private Label Productions LLC?
Nydia E. Colon is named on this Form 483, for the inspection of Feb 6 – Feb 9, 2024. Each investigator has a profile showing what they cite most.
When was Private Label Productions LLC inspected by FDA?
The inspection ran Feb 6 – Feb 9, 2024, and the Form 483 is dated February 9, 2024.
How do I get the full Form 483 for Private Label Productions 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.