Modavar Pharmaceuticals
Form 483 issued January 27, 2023 · Frederick, Maryland
- Inspection
- Jan 18 – Jan 27, 2023
- Investigators
- Amy N. Chen· Jazmine N. Brown· Kathleen M. Jordan
- Observations
- 8
- Pages
- 8
- FEI number
- 3014525970
In short: On January 27, 2023, FDA issued a Form 483 with 8 observations to Modavar Pharmaceuticals in Frederick, Maryland (FEI 3014525970) after an inspection that ran Jan 18 – Jan 27, 2023. The investigators were Amy N. Chen, Jazmine N. Brown and Kathleen M. Jordan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
The written stability program for drug products does not include sample size based on statistical criteria…
This inspection in context
Amy N. Chen
8 documents · 2022–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmModavar Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Modavar Pharmaceuticals?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Modavar Pharmaceuticals?
Amy N. Chen, Jazmine N. Brown and Kathleen M. Jordan are named on this Form 483, for the inspection of Jan 18 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was Modavar Pharmaceuticals inspected by FDA?
The inspection ran Jan 18 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for Modavar Pharmaceuticals?
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.