Packaging Coordinators, LLC
Form 483 issued October 21, 2022 · Philadelphia, Pennsylvania
- Inspection
- Oct 17 – Oct 21, 2022
- Investigators
- Anastasia M. Shields· Thai D. Truong· Thomas R. Withers
- Observations
- 2
- Pages
- 3
- FEI number
- 1000522077
In short: On October 21, 2022, FDA issued a Form 483 with 2 observations to Packaging Coordinators, LLC in Philadelphia, Pennsylvania (FEI 1000522077) after an inspection that ran Oct 17 – Oct 21, 2022. The investigators were Anastasia M. Shields, Thai D. Truong and Thomas R. Withers. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.56(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmPackaging Coordinators, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Packaging Coordinators, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Packaging Coordinators, LLC?
Anastasia M. Shields, Thai D. Truong and Thomas R. Withers are named on this Form 483, for the inspection of Oct 17 – Oct 21, 2022. Each investigator has a profile showing what they cite most.
When was Packaging Coordinators, LLC inspected by FDA?
The inspection ran Oct 17 – Oct 21, 2022, and the Form 483 is dated October 21, 2022.
How do I get the full Form 483 for Packaging Coordinators, LLC?
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