Pharmatech LLC
Form 483 issued May 2, 2017 · Davie, Florida
- Inspection
- Mar 20 – May 2, 2017
- Investigators
- Jennifer Lalama· Marc Balzarini· Rozelle G. Smith
- Observations
- 10
- Pages
- 13
- FEI number
- 3008328782
In short: On May 2, 2017, FDA issued a Form 483 with 10 observations to Pharmatech LLC in Davie, Florida (FEI 3008328782) after an inspection that ran Mar 20 – May 2, 2017. The investigators were Jennifer Lalama, Marc Balzarini and Rozelle G. Smith. Most observations concern dietary supplement CGMP and quality system.
At a glance
Observations span 4 systems, led by dietary supplement cgmp.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmPharmatech LLC 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 Pharmatech LLC?
FDA listed 10 observations on this Form 483, mostly about dietary supplement CGMP, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmatech LLC?
Jennifer Lalama, Marc Balzarini and Rozelle G. Smith are named on this Form 483, for the inspection of Mar 20 – May 2, 2017. Each investigator has a profile showing what they cite most.
When was Pharmatech LLC inspected by FDA?
The inspection ran Mar 20 – May 2, 2017, and the Form 483 is dated May 2, 2017.
How do I get the full Form 483 for Pharmatech 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.