Legacy Pharmaceutical Pa.c kaging LLC
Form 483 issued January 16, 2020 · Earth Ci ty, Missouri
- Inspection
- Jan 13 – Jan 16, 2020
- Investigator
- Edward E. Lockwood
- Observations
- 5
- Pages
- 5
- FEI number
- 3004453700
In short: On January 16, 2020, FDA issued a Form 483 with 5 observations to Legacy Pharmaceutical Pa.c kaging LLC in Earth Ci ty, Missouri (FEI 3004453700) after an inspection that ran Jan 13 – Jan 16, 2020. The investigator was Edward E. Lockwood. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
3 of 5 observations on this 483 concern capa.
Most cited: 21 CFR 820.90 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Rework and reevaluation activities have not been documented in…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Schedules for the adjustment, cleaning, and other maintenance of equipment…
This inspection in context
Edward E. Lockwood
5 documents · 2018–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Missouri.
The firmLegacy Pharmaceutical Pa.c kaging LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.90
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Legacy Pharmaceutical Pa.c kaging LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Legacy Pharmaceutical Pa.c kaging LLC?
Edward E. Lockwood is named on this Form 483, for the inspection of Jan 13 – Jan 16, 2020. Each investigator has a profile showing what they cite most.
When was Legacy Pharmaceutical Pa.c kaging LLC inspected by FDA?
The inspection ran Jan 13 – Jan 16, 2020, and the Form 483 is dated January 16, 2020.
How do I get the full Form 483 for Legacy Pharmaceutical Pa.c kaging LLC?
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.