Pine Pharmacy and Home Care Products Center, Inc.
Form 483 issued April 18, 2016 · Williamsvil le, New York
- Inspection
- Mar 30 – Apr 18, 2016
- Investigator
- Karen L. Kosar
- Observations
- 8
- Pages
- 4
- FEI number
- 3010285019
In short: On April 18, 2016, FDA issued a Form 483 with 8 observations to Pine Pharmacy and Home Care Products Center, Inc. in Williamsvil le, New York (FEI 3010285019) after an inspection that ran Mar 30 – Apr 18, 2016. The investigator was Karen L. Kosar. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and production account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Protective apparel is not worn as necessary to protect…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Karen L. Kosar
4 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) 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 211.42
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 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Pine Pharmacy and Home Care Products Center, Inc.?
Karen L. Kosar is named on this Form 483, for the inspection of Mar 30 – Apr 18, 2016. 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 Mar 30 – Apr 18, 2016, and the Form 483 is dated April 18, 2016.
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.