Liberty Drug & Surgical
Form 483 issued May 22, 2015 · Chatham, New Jersey
- Inspection
- Mar 30 – May 22, 2015
- Investigators
- Barbara J. Wilimczyk-Macri· Frederick Razzaghi· Philip F. Istafanos
- Observations
- 13
- Pages
- 5
- FEI number
- 3002127548
In short: On May 22, 2015, FDA issued a Form 483 with 13 observations to Liberty Drug & Surgical in Chatham, New Jersey (FEI 3002127548) after an inspection that ran Mar 30 – May 22, 2015. The investigators were Barbara J. Wilimczyk-Macri, Frederick Razzaghi, Philip F. Istafanos and Susan T. Hadman. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 13 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The flow of components, drug product containers,. closures, in-process materials, and drug products though the building…
- 02
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Barbara J. Wilimczyk-Macri
5 documents · 2012–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmLiberty Drug & Surgical history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Liberty Drug & Surgical?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Liberty Drug & Surgical?
Barbara J. Wilimczyk-Macri, Frederick Razzaghi, Philip F. Istafanos and Susan T. Hadman are named on this Form 483, for the inspection of Mar 30 – May 22, 2015. Each investigator has a profile showing what they cite most.
When was Liberty Drug & Surgical inspected by FDA?
The inspection ran Mar 30 – May 22, 2015, and the Form 483 is dated May 22, 2015.
How do I get the full Form 483 for Liberty Drug & Surgical?
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