Actavis Laboratories, FL, Inc
Form 483 issued December 1, 2017 · Sunrise, Florida
- Inspection
- Nov 29 – Dec 1, 2017
- Investigator
- Libia M. Lugo
- Observations
- 3
- Pages
- 4
- FEI number
- 3003937591
In short: On December 1, 2017, FDA issued a Form 483 with 3 observations to Actavis Laboratories, FL, Inc in Sunrise, Florida (FEI 3003937591) after an inspection that ran Nov 29 – Dec 1, 2017. The investigator was Libia M. Lugo. Most observations concern packaging & labeling and quality system; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
2 of 3 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.130 (2×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspection of the packaging facilities is not done after use to assure that materials not suitable…
- 02
Filled drug product containers which are set aside and held in an unlabeled condition are not…
- 03
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmActavis Laboratories, FL, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Actavis Laboratories, FL, Inc?
FDA listed 3 observations on this Form 483, mostly about packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected Actavis Laboratories, FL, Inc?
Libia M. Lugo is named on this Form 483, for the inspection of Nov 29 – Dec 1, 2017. Each investigator has a profile showing what they cite most.
When was Actavis Laboratories, FL, Inc inspected by FDA?
The inspection ran Nov 29 – Dec 1, 2017, and the Form 483 is dated December 1, 2017.
How do I get the full Form 483 for Actavis Laboratories, FL, 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.