Pine Pharmacy and Home Care Products Center, Inc.
Form 483 issued July 19, 2013 · Williamsvil le, New York
- Inspection
- Jul 16 – Jul 19, 2013
- Investigators
- James A. Liubicich· Karen L. Kosar
- Observations
- 10
- Pages
- 5
- FEI number
- 3010285019
In short: On July 19, 2013, FDA issued a Form 483 with 10 observations to Pine Pharmacy and Home Care Products Center, Inc. in Williamsvil le, New York (FEI 3010285019) after an inspection that ran Jul 16 – Jul 19, 2013. The investigators were James A. Liubicich and Karen L. Kosar. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Clothing of personnel engaged in the processing of dmg products is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air…
This inspection in context
James A. Liubicich
13 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPine Pharmacy and Home Care Products Center, Inc. history
All 6 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 Pine Pharmacy and Home Care Products Center, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pine Pharmacy and Home Care Products Center, Inc.?
James A. Liubicich and Karen L. Kosar are named on this Form 483, for the inspection of Jul 16 – Jul 19, 2013. Each investigator has a profile showing what they cite most.
When was Pine Pharmacy and Home Care Products Center, Inc. inspected by FDA?
The inspection ran Jul 16 – Jul 19, 2013, and the Form 483 is dated July 19, 2013.
How do I get the full Form 483 for Pine Pharmacy and Home Care Products Center, 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.