Form FDA 483 Merck Teknika LLC Durham November 2024
Form 483 issued November 27, 2024 · Du rham, North Carolina
- Inspection
- Nov 19 – Nov 27, 2024
- Investigator
- Lizai Da Pe Rez
- Observations
- 6
- Pages
- 8
In short: On November 27, 2024, FDA issued a Form 483 with 6 observations to Form FDA 483 Merck Teknika LLC Durham November 2024 in Du rham, North Carolina after an inspection that ran Nov 19 – Nov 27, 2024. The investigator was Lizai Da Pe Rez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Lizai Da Pe Rez
1 document · 2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmForm FDA 483 Merck Teknika LLC Durham November 2024 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Form FDA 483 Merck Teknika LLC Durham November 2024?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Form FDA 483 Merck Teknika LLC Durham November 2024?
Lizai Da Pe Rez is named on this Form 483, for the inspection of Nov 19 – Nov 27, 2024. Each investigator has a profile showing what they cite most.
When was Form FDA 483 Merck Teknika LLC Durham November 2024 inspected by FDA?
The inspection ran Nov 19 – Nov 27, 2024, and the Form 483 is dated November 27, 2024.
How do I get the full Form 483 for Form FDA 483 Merck Teknika LLC Durham November 2024?
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.