Merck Teknika LLC
Form 483 issued January 24, 2020 · Durham, North Carolina
- Inspection
- Jan 14 – Jan 24, 2020
- Investigators
- Marla A. Cassidy· Mihaly S. Ligmond· Steven E. Bowen
- Observations
- 10
- Pages
- 5
- FEI number
- 1039284
In short: On January 24, 2020, FDA issued a Form 483 with 10 observations to Merck Teknika LLC in Durham, North Carolina (FEI 1039284) after an inspection that ran Jan 14 – Jan 24, 2020. The investigators were Marla A. Cassidy, Mihaly S. Ligmond and Steven E. Bowen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Your (A) and drug products were not determined by the application…
This inspection in context
Marla A. Cassidy
2 documents · 2020–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmMerck Teknika LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Teknika LLC?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Merck Teknika LLC?
Marla A. Cassidy, Mihaly S. Ligmond and Steven E. Bowen are named on this Form 483, for the inspection of Jan 14 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was Merck Teknika LLC inspected by FDA?
The inspection ran Jan 14 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Merck Teknika 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.