Pentec Health
Form 483 issued February 23, 2018 · Boothwyn, Pennsylvania
- Inspection
- Feb 5 – Feb 23, 2018
- Investigators
- Christina K. Theodorou· Lisa B. Orr
- Observations
- 5
- Pages
- 3
- FEI number
- 3012746140
In short: On February 23, 2018, FDA issued a Form 483 with 5 observations to Pentec Health in Boothwyn, Pennsylvania (FEI 3012746140) after an inspection that ran Feb 5 – Feb 23, 2018. The investigators were Christina K. Theodorou and Lisa B. Orr. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPentec Health history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pentec Health?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Pentec Health?
Christina K. Theodorou and Lisa B. Orr are named on this Form 483, for the inspection of Feb 5 – Feb 23, 2018. Each investigator has a profile showing what they cite most.
When was Pentec Health inspected by FDA?
The inspection ran Feb 5 – Feb 23, 2018, and the Form 483 is dated February 23, 2018.
How do I get the full Form 483 for Pentec Health?
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.