Mckesson Packaging Services
Form 483 issued December 15, 2017 · Concord, North Carolina
- Inspection
- Dec 12 – Dec 15, 2017
- Investigators
- Jared P. Stevens· Susan O. Oladeji
- Observations
- 2
- Pages
- 2
In short: On December 15, 2017, FDA issued a Form 483 with 2 observations to Mckesson Packaging Services in Concord, North Carolina after an inspection that ran Dec 12 – Dec 15, 2017. The investigators were Jared P. Stevens and Susan O. Oladeji. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
The batch production and control records are deficient in that they do not include results of…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmMckesson Packaging Services history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mckesson Packaging Services?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Mckesson Packaging Services?
Jared P. Stevens and Susan O. Oladeji are named on this Form 483, for the inspection of Dec 12 – Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was Mckesson Packaging Services inspected by FDA?
The inspection ran Dec 12 – Dec 15, 2017, and the Form 483 is dated December 15, 2017.
How do I get the full Form 483 for Mckesson Packaging Services?
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.