GERRESHEIMER PEACHTREE CITY LP
Form 483 issued December 12, 2022 · Peachtree City, Georgia
- Inspection
- Nov 18 – Dec 12, 2022
- Investigators
- Miaja Umaedi· Susan O. Oladeji
- Observations
- 4
- Pages
- 3
- FEI number
- 3013445959
In short: On December 12, 2022, FDA issued a Form 483 with 4 observations to GERRESHEIMER PEACHTREE CITY LP in Peachtree City, Georgia (FEI 3013445959) after an inspection that ran Nov 18 – Dec 12, 2022. The investigators were Miaja Umaedi and Susan O. Oladeji. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 4 of 4 observations.
Most cited: 21 CFR 211.192 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for sampling and testing plans are not followed…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Miaja Umaedi
4 documents · 2015–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmGERRESHEIMER PEACHTREE CITY LP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GERRESHEIMER PEACHTREE CITY LP?
FDA listed 4 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected GERRESHEIMER PEACHTREE CITY LP?
Miaja Umaedi and Susan O. Oladeji are named on this Form 483, for the inspection of Nov 18 – Dec 12, 2022. Each investigator has a profile showing what they cite most.
When was GERRESHEIMER PEACHTREE CITY LP inspected by FDA?
The inspection ran Nov 18 – Dec 12, 2022, and the Form 483 is dated December 12, 2022.
How do I get the full Form 483 for GERRESHEIMER PEACHTREE CITY LP?
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.