Transdermal Delivery Solutions Corp, dba
Form 483 issued December 3, 2019 · Palm Beach Gardens, Florida
- Inspection
- Dec 2 – Dec 3, 2019
- Investigator
- Jennifer L. Huntington
- Observations
- 5
- Pages
- 4
- FEI number
- 3010178539
In short: On December 3, 2019, FDA issued a Form 483 with 5 observations to Transdermal Delivery Solutions Corp, dba in Palm Beach Gardens, Florida (FEI 3010178539) after an inspection that ran Dec 2 – Dec 3, 2019. The investigator was Jennifer L. Huntington. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Ding products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmTransdermal Delivery Solutions Corp, dba history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Transdermal Delivery Solutions Corp, dba?
FDA listed 5 observations on this Form 483, mostly about quality system, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Transdermal Delivery Solutions Corp, dba?
Jennifer L. Huntington is named on this Form 483, for the inspection of Dec 2 – Dec 3, 2019. Each investigator has a profile showing what they cite most.
When was Transdermal Delivery Solutions Corp, dba inspected by FDA?
The inspection ran Dec 2 – Dec 3, 2019, and the Form 483 is dated December 3, 2019.
How do I get the full Form 483 for Transdermal Delivery Solutions Corp, dba?
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.