Pharma Pac, LLC
Form 483 issued August 9, 2019 · De Kalb, Mississippi
- Inspection
- Aug 7 – Aug 9, 2019
- Investigator
- Susan O. Oladeji
- Observations
- 6
- Pages
- 4
- FEI number
- 3003982004
In short: On August 9, 2019, FDA issued a Form 483 with 6 observations to Pharma Pac, LLC in De Kalb, Mississippi (FEI 3003982004) after an inspection that ran Aug 7 – Aug 9, 2019. The investigator was Susan O. Oladeji. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmPharma Pac, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharma Pac, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pharma Pac, LLC?
Susan O. Oladeji is named on this Form 483, for the inspection of Aug 7 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Pharma Pac, LLC inspected by FDA?
The inspection ran Aug 7 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
How do I get the full Form 483 for Pharma Pac, 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.