Pallimed Solutions, Inc. 400
Amended 483 issued April 9, 2013 · Woburn, Massachusetts
- Inspection
- Mar 20 – Apr 9, 2013
- Investigator
- Ramon E. Martinez
- Observations
- 13
- Pages
- 15
- FEI number
- 3010084286
In short: On April 9, 2013, FDA issued a Amended 483 with 13 observations to Pallimed Solutions, Inc. 400 in Woburn, Massachusetts (FEI 3010084286) after an inspection that ran Mar 20 – Apr 9, 2013. The investigator was Ramon E. Martinez. 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.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 02
Buildings used in the processing, packing, and holding ofa drug product are not maintained inn…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
- 04
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…
9 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Ramon E. Martinez
5 documents · 2012–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPallimed Solutions, Inc. 400 history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Pallimed Solutions, Inc. 400?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Pallimed Solutions, Inc. 400?
Ramon E. Martinez is named on this Amended 483, for the inspection of Mar 20 – Apr 9, 2013. Each investigator has a profile showing what they cite most.
When was Pallimed Solutions, Inc. 400 inspected by FDA?
The inspection ran Mar 20 – Apr 9, 2013, and the Amended 483 is dated April 9, 2013.
How do I get the full Amended 483 for Pallimed Solutions, Inc. 400?
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.