Synergy Pharmacy Services, Inc.
Form 483 issued June 21, 2016 · Palm Harbor, Florida
- Inspection
- Jun 14 – Jun 21, 2016
- Investigator
- Noreen Muniz
- Observations
- 7
- Pages
- 4
- FEI number
- 3011761363
In short: On June 21, 2016, FDA issued a Form 483 with 7 observations to Synergy Pharmacy Services, Inc. in Palm Harbor, Florida (FEI 3011761363) after an inspection that ran Jun 14 – Jun 21, 2016. The investigator was Noreen Muniz. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug product.c; purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system for…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the areas and equipment…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSynergy Pharmacy Services, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Synergy Pharmacy Services, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Synergy Pharmacy Services, Inc.?
Noreen Muniz is named on this Form 483, for the inspection of Jun 14 – Jun 21, 2016. Each investigator has a profile showing what they cite most.
When was Synergy Pharmacy Services, Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 21, 2016, and the Form 483 is dated June 21, 2016.
How do I get the full Form 483 for Synergy Pharmacy Services, 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.