Pentec Health, Inc.
Form 483 issued April 1, 2013 · Boothwyn, Pennsylvania
- Inspection
- Mar 18 – Apr 1, 2013
- Investigators
- Anita R. Michael· Julianne C. McCullough
- Observations
- 9
- Pages
- 9
- FEI number
- 3006489293
In short: On April 1, 2013, FDA issued a Form 483 with 9 observations to Pentec Health, Inc. in Boothwyn, Pennsylvania (FEI 3006489293) after an inspection that ran Mar 18 – Apr 1, 2013. The investigators were Anita R. Michael and Julianne C. McCullough. 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.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Clothing ofpersonnel engaged in the ofdrug products is not appropriate for…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPentec Health, Inc. history
All 2 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 Pentec Health, Inc.?
FDA listed 9 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 Pentec Health, Inc.?
Anita R. Michael and Julianne C. McCullough are named on this Form 483, for the inspection of Mar 18 – Apr 1, 2013. Each investigator has a profile showing what they cite most.
When was Pentec Health, Inc. inspected by FDA?
The inspection ran Mar 18 – Apr 1, 2013, and the Form 483 is dated April 1, 2013.
How do I get the full Form 483 for Pentec Health, 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.